Back to results

A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC) (PROTECT)

Primary Purpose

Renal Cell Carcinoma (RCC), Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

pazopanib

placebo

pazopanib

placebo

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma (RCC) focused on measuring anti-angiogenic agent, renal cell carcinoma, pazopanib, adjuvant therapy, VEGFR inhibitor, localized or locally, advanced renal cell carcinoma (RCC) following nephrectomy, advanced RCC, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed written informed consent
Diagnosis of RCC with clear-cell or predominant clear-cell histology
Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 and Fuhrman nuclear grading.
- pT2, G3 or G4, N0; or,
- pT3, G any, N0; or,
- pT4, G any, N0; or,
- pT any, G any, N1
Fulfill all of the following criteria of disease-free status at baseline:
- Had complete gross surgical resection of all RCC via radical or partial nephrectomy using either open or laparoscopic technique.
- Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist.
Received no prior adjuvant or neo-adjuvant treatment for RCC
Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤ grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4)
Karnofsky performance scale (KPS) of ≥ 80
Adequate organ system function

Exclusion Criteria:

History of another malignancy. Exception: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- Active peptic ulcer disease
- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
Active diarrhea of any grade
Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- Malabsorption syndrome
- Major resection of the stomach or small bowel
History of human immunodeficiency virus (HIV) infection
History of active hepatitis
Presence of uncontrolled infection.
History of any one or more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Coronary artery bypass graft surgery
- Symptomatic peripheral vascular disease
History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
Corrected QT interval (QTc) > 480 milliseconds (msec)
Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg.

Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study (see Section 7.6.2 for instruction on blood pressure measurement and obtaining mean blood pressure values).

Evidence of active bleeding or bleeding diathesis
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment and for the duration of the study.
Concurrent therapy given to treat cancer including treatment with an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug.
Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or excipients that in the opinion of the investigator contraindicates their participation.
Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon, interleukin 2).

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pazopanib

placebo

Arm Description

Pazopanib oral agent, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.

placebo matching pazopanib 200 mg tablets, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.

Outcomes

Primary Outcome Measures

Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

Secondary Outcome Measures

Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo

Overall survival is defined as the time from randomization until death due to any cause. For subjects who did not die, time to death was censored at the last date of known contact.

DFS Rates at Yearly Time Points With Pazopanib 600 mg Daily Initial Dose vs. Placebo

DFS With Pazopanib vs. Placebo

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

OS With Pazopanib vs. Placebo

Overall survival is defined as the time from randomization until death due to any cause. For subjects who do not die, time to death will be censored at the last date of known contact.

DFS Rates at Yearly Time Points With Pazopanib vs. Placebo

DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

OS With Pazopanib 800 mg Daily Initial Dose vs. Placebo

Overall survival is defined as the time from randomization until death due to any cause. For subjects who did not die, time to death was censored at the last date of known contact.

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative mean indicates a worsening of condition.

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative mean indicates a worsening of condition.

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score

Health outcome and quality of life measured by EQ-5D thermometer (thermo) score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score

Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative mean indicates a worsening of condition.

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4).A negative mean indicates a worsening of condition.

Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score

Health outcome and quality of life measured by using EQ-5D thermometer score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Full Information

NCT ID

NCT01235962

First Posted

October 14, 2010

Last Updated

October 29, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01235962

Brief Title

A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)

Acronym

PROTECT

Official Title

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

November 30, 2010 (Actual)

Primary Completion Date

October 15, 2015 (Actual)

Study Completion Date

April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

Detailed Description

The primary objective of this ongoing study was to evaluate DFS with pazopanib 600 mg daily initial dose as compared with placebo as adjuvant therapy for subjects with localized/locally advanced RCC following nephrectomy. Subjects with locally recurrent renal cell carcinoma (RCC), bilateral RCC, or history of another malignancy were excluded from enrolling in the study. The study was comprised of three successive study periods: 1) the Screening/Baseline period, 2) the study treatment period, and 3) the DFS /OS follow-up period. The Screening/Baseline period had a maximum duration of 12 weeks from the date of nephrectomy to the date of randomization. After a subject met all the eligibility criteria and completed all the required baseline assessments, the subject was randomized in a 1:1 ratio to receive once daily blinded treatment with either pazopanib 600 mg as initial dose or matching placebo based on pre-defined stratification factors. Subjects received continuous daily treatment until completion of the 12-month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed. During the study treatment and DFS follow-up periods, subjects received routine safety and efficacy assessments. The study treatment period was 12 months. Subjects received continuous daily treatment until completion of the 12 month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed. All subjects, regardless of study treatment status (i.e. premature discontinuation or completion of the 12-month treatment), were to be followed with routine imaging assessments and remain blinded until objective evidence of disease recurrence was obtained or until the study achieved the required number of events for the primary endpoint of DFS (319 events). After objective evidence of disease recurrence was obtained, subjects could be unblinded and received the first-line treatment for metastatic RCC per local standard of care. All subjects were off treatment for at least 4 years at the end of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma (RCC), Cancer

Keywords

anti-angiogenic agent, renal cell carcinoma, pazopanib, adjuvant therapy, VEGFR inhibitor, localized or locally, advanced renal cell carcinoma (RCC) following nephrectomy, advanced RCC, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1538 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pazopanib

Arm Type

Experimental

Arm Description

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

pazopanib

Other Intervention Name(s)

PZP034

Intervention Description

Pazopanib monohydrochloride salt was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo matching pazopanib was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.

Intervention Type

Drug

Intervention Name(s)

pazopanib

Other Intervention Name(s)

Votrient

Intervention Description

Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

Primary Outcome Measure Information:

Title

Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo

Description

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

Time Frame

approximately 5 years

Secondary Outcome Measure Information:

Title

Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo

Description

Overall survival is defined as the time from randomization until death due to any cause. For subjects who did not die, time to death was censored at the last date of known contact.

Time Frame

approximately 8.5 years

Title

DFS Rates at Yearly Time Points With Pazopanib 600 mg Daily Initial Dose vs. Placebo

Time Frame

yearly for 4 years

Title

DFS With Pazopanib vs. Placebo

Description

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

Time Frame

approximately 5 years

Title

OS With Pazopanib vs. Placebo

Description

Overall survival is defined as the time from randomization until death due to any cause. For subjects who do not die, time to death will be censored at the last date of known contact.

Time Frame

approximately 8.5 years

Title

DFS Rates at Yearly Time Points With Pazopanib vs. Placebo

Time Frame

yearly for 4 years

Title

DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo

Description

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

Time Frame

approximately 5 years

Title

OS With Pazopanib 800 mg Daily Initial Dose vs. Placebo

Description

Overall survival is defined as the time from randomization until death due to any cause. For subjects who did not die, time to death was censored at the last date of known contact.

Time Frame

approximately 8.5 years

Title

Description

Time Frame

Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Title

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score

Description

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative mean indicates a worsening of condition.

Time Frame

Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Title

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score

Description

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative mean indicates a worsening of condition.

Time Frame

Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU

Title

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score

Description

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Time Frame

Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU

Title

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score

Description

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Time Frame

Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU

Title

Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score

Description

Time Frame

Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Title

Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score

Description

Time Frame

Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Title

Description

Time Frame

Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Title

Description

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4).A negative mean indicates a worsening of condition.

Time Frame

Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Title

Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score

Description

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Time Frame

Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Title

Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score

Description

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Time Frame

Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Title

Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score

Description

Time Frame

Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed written informed consent Diagnosis of RCC with clear-cell or predominant clear-cell histology Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 and Fuhrman nuclear grading. pT2, G3 or G4, N0; or, pT3, G any, N0; or, pT4, G any, N0; or, pT any, G any, N1 Fulfill all of the following criteria of disease-free status at baseline: Had complete gross surgical resection of all RCC via radical or partial nephrectomy using either open or laparoscopic technique. Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist. Received no prior adjuvant or neo-adjuvant treatment for RCC Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤ grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4) Karnofsky performance scale (KPS) of ≥ 80 Adequate organ system function Exclusion Criteria: History of another malignancy. Exception: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: Active peptic ulcer disease Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment Active diarrhea of any grade Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: Malabsorption syndrome Major resection of the stomach or small bowel History of human immunodeficiency virus (HIV) infection History of active hepatitis Presence of uncontrolled infection. History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting Myocardial infarction Unstable angina Coronary artery bypass graft surgery Symptomatic peripheral vascular disease History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Corrected QT interval (QTc) > 480 milliseconds (msec) Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study (see Section 7.6.2 for instruction on blood pressure measurement and obtaining mean blood pressure values). Evidence of active bleeding or bleeding diathesis Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment and for the duration of the study. Concurrent therapy given to treat cancer including treatment with an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or excipients that in the opinion of the investigator contraindicates their participation. Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon, interleukin 2).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Novartis Investigative Site

City

Antioch

State/Province

California

ZIP/Postal Code

94531

Country

United States

Facility Name

Novartis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Novartis Investigative Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Novartis Investigative Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048-0750

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Novartis Investigative Site

City

Oakland

State/Province

California

ZIP/Postal Code

94611

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Novartis Investigative Site

City

South San Francisco

State/Province

California

ZIP/Postal Code

94080

Country

United States

Facility Name

Novartis Investigative Site

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Novartis Investigative Site

City

Vallejo

State/Province

California

ZIP/Postal Code

94589

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Novartis Investigative Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Novartis Investigative Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Novartis Investigative Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Novartis Investigative Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68118

Country

United States

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

Novartis Investigative Site

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Novartis Investigative Site

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Novartis Investigative Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Novartis Investigative Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Oregon

ZIP/Postal Code

97477

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Novartis Investigative Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Novartis Investigative Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novartis Investigative Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Novartis Investigative Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Novartis Investigative Site

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Novartis Investigative Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

Facility Name

Novartis Investigative Site

City

Hampton

State/Province

Virginia

ZIP/Postal Code

23666

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

Novartis Investigative Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23462

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Novartis Investigative Site

City

Berazategui

State/Province

Buenos Aires

ZIP/Postal Code

B1880BBF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Aut6noma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1050AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1405BCH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

1878

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Córdova

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Córdova

ZIP/Postal Code

X5006HBF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cipolletti

State/Province

Río Negro

ZIP/Postal Code

R8324EMB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000KZE

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

ZIP/Postal Code

T4000IAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

A-5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1130

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

A-1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Jette

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Novartis Investigative Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-100

Country

Brazil

Facility Name

Novartis Investigative Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

81520-060

Country

Brazil

Facility Name

Novartis Investigative Site

City

Ijui

State/Province

Rio Grande Do Sul

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Barretos

State/Province

São Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Novartis Investigative Site

City

Campinas

State/Province

São Paulo

ZIP/Postal Code

13083-970

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

01308-050

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

05651-901

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

08270-070

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

ZIP/Postal Code

20 551-030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Novartis Investigative Site

City

Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

7500921

Country

Chile

Facility Name

Novartis Investigative Site

City

Vina del Mar

State/Province

Valparaíso

ZIP/Postal Code

254-0364

Country

Chile

Facility Name

Novartis Investigative Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200127

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

ZIP/Postal Code

300060

Country

China

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Novy Jicin

ZIP/Postal Code

741 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava - Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

ZIP/Postal Code

304 60

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 2

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 8

ZIP/Postal Code

180 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Usti nad Labem

ZIP/Postal Code

40113

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aarhus

ZIP/Postal Code

8000 Aarhus C

Country

Denmark

Facility Name

Novartis Investigative Site

City

Dk-2730 Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Novartis Investigative Site

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Novartis Investigative Site

City

ANGERS Cedex 2

ZIP/Postal Code

49055

Country

France

Facility Name

Novartis Investigative Site

City

Besancon cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Novartis Investigative Site

City

Caen Cedex

ZIP/Postal Code

14076

Country

France

Facility Name

Novartis Investigative Site

City

Hyeres

ZIP/Postal Code

83400

Country

France

Facility Name

Novartis Investigative Site

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Novartis Investigative Site

City

Marseille cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 15

ZIP/Postal Code

75908

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Novartis Investigative Site

City

Poitiers Cedex

ZIP/Postal Code

86021

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Novartis Investigative Site

City

Rennes

ZIP/Postal Code

35042

Country

France

Facility Name

Novartis Investigative Site

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg cedex

ZIP/Postal Code

67085

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg Cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31076

Country

France

Facility Name

Novartis Investigative Site

City

Tours Cedex 9

ZIP/Postal Code

37044

Country

France

Facility Name

Novartis Investigative Site

City

Kirchheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73230

Country

Germany

Facility Name

Novartis Investigative Site

City

Ravensburg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

88212

Country

Germany

Facility Name

Novartis Investigative Site

City

Sigmaringen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72488

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

70174

Country

Germany

Facility Name

Novartis Investigative Site

City

Tuebingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89075

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

State/Province

Bayern

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Fuerth

State/Province

Bayern

ZIP/Postal Code

90766

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bayern

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Weiden

State/Province

Bayern

ZIP/Postal Code

92637

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

State/Province

Hessen

ZIP/Postal Code

35043

Country

Germany

Facility Name

Novartis Investigative Site

City

Offenbach

State/Province

Hessen

ZIP/Postal Code

63069

Country

Germany

Facility Name

Novartis Investigative Site

City

Braunschweig

State/Province

Niedersachsen

ZIP/Postal Code

38126

Country

Germany

Facility Name

Novartis Investigative Site

City

Goslar

State/Province

Niedersachsen

ZIP/Postal Code

38642

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novartis Investigative Site

City

Bergisch Gladbach

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51465

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47179

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Novartis Investigative Site

City

Moenchengladbach

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41063

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuss

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41464

Country

Germany

Facility Name

Novartis Investigative Site

City

Velbert

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

42551

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Homburg

State/Province

Saarland

ZIP/Postal Code

66421

Country

Germany

Facility Name

Novartis Investigative Site

City

Dessau

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06846

Country

Germany

Facility Name

Novartis Investigative Site

City

Eisleben

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06295

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

State/Province

Sachsen

ZIP/Postal Code

09130

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04277

Country

Germany

Facility Name

Novartis Investigative Site

City

Plauen

State/Province

Sachsen

ZIP/Postal Code

08523

Country

Germany

Facility Name

Novartis Investigative Site

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23566

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

State/Province

Thueringen

ZIP/Postal Code

07768

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10719

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10967

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28177

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 22

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion, Crete

ZIP/Postal Code

71100

Country

Greece

Facility Name

Novartis Investigative Site

City

Patra

ZIP/Postal Code

26504

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1082

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Cork

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Galway

Country

Ireland

Facility Name

Novartis Investigative Site

City

Tallaght, Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novartis Investigative Site

City

Zrifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Novartis Investigative Site

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Meldola (FC)

State/Province

Emilia-Romagna

ZIP/Postal Code

47014

Country

Italy

Facility Name

Novartis Investigative Site

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00152

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Rozzano (MI)

State/Province

Lombardia

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Candiolo (TO)

State/Province

Piemonte

ZIP/Postal Code

10060

Country

Italy

Facility Name

Novartis Investigative Site

City

Arezzo

State/Province

Toscana

ZIP/Postal Code

52100

Country

Italy

Facility Name

Novartis Investigative Site

City

Terni

State/Province

Umbria

ZIP/Postal Code

05100

Country

Italy

Facility Name

Novartis Investigative Site

City

Negrar

State/Province

Veneto

ZIP/Postal Code

37024

Country

Italy

Facility Name

Novartis Investigative Site

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Hokkaido

ZIP/Postal Code

060-8543

Country

Japan

Facility Name

Novartis Investigative Site

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Novartis Investigative Site

City

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

Novartis Investigative Site

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Shizuoka

ZIP/Postal Code

431-3192

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

162-8666

Country

Japan

Facility Name

Novartis Investigative Site

City

Yamagata

ZIP/Postal Code

990-9585

Country

Japan

Facility Name

Novartis Investigative Site

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Goyang-si, Gyeonggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Jeonju-si

ZIP/Postal Code

54907

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seongnam-si Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Songpa-gu, Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Luxembourg

ZIP/Postal Code

1210

Country

Luxembourg

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

Novartis Investigative Site

City

Konin

ZIP/Postal Code

62-500

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-108

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-115

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04-125

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Novartis Investigative Site

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656049

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Obninsk

ZIP/Postal Code

249036

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Rostov-na-Donu

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Stavropol

ZIP/Postal Code

355047

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ufa,

ZIP/Postal Code

450054

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

041 66

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

012 07

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Dos Hermanas (Sevilla)

ZIP/Postal Code

41700

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Brighton

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cornwall

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Preston

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Swansea

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

20100962

Citation

Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarba JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.

Results Reference

background

PubMed Identifier

33461782

Citation

Motzer RJ, Russo P, Haas N, Doehn C, Donskov F, Gross-Goupil M, Varlamov S, Kopyltsov E, Lee JL, Lim HY, Melichar B, Zemanova M, Rini B, Choueiri TK, Wood L, Reaume MN, Stenzl A, Chowdhury S, McDermott R, Michael A, Izquierdo M, Aimone P, Zhang H, Sternberg CN; PROTECT study investigators. Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma: Final Overall Survival Analysis of the Phase 3 PROTECT Trial. Eur Urol. 2021 Mar;79(3):334-338. doi: 10.1016/j.eururo.2020.12.029. Epub 2021 Jan 15.

Results Reference

derived

Learn more about this trial

A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)

We'll reach out to this number within 24 hrs

A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC) (PROTECT)

Renal Cell Carcinoma (RCC), Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial