Back to results

Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

Primary Purpose

Metastatic Renal Cell Carcinoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dovitinib

Sorafenib

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring Dovitinib, TKI, Renal cell cancer, RCC, mRCC

Eligibility Criteria

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

Inclusion Criteria:

Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell
Patients must have received one and only one prior VEGF-targeted therapy and one and only one prior mTOR inhibitor therapy in the metastatic setting. One VEGF targeted therapy (e.g. sunitinib, or pazopanib, or axitinib, or tivozanib or bevacizumab) and one prior mTOR inhibitor therapy (everolimus, or temsirolimus or ridaforolimus)
Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted.
Patients must have had disease progression on or within 6 months of stopping the last therapy.
Patients must have at least one measurable lesion at baseline (by RECIST Criteria Guidelines v1.1) assessed by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).
Karnofsky performance status ≥ 70%
Patients must have the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin (Hgb) > 9 g/dL
- Serum total bilirubin: ≤ 1.5 x ULN
- ALT and AST ≤ 3.0 x ULN (Patients with known liver metastases: AST and ALT ≤ 5.0 x ULN)
- Serum creatinine ≤ 1.5 x ULN

Exclusion Criteria:

Patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant or metastatic setting.
Patients who have previously received Dovitinib or brivanib in the neoadjuvant, adjuvant or metastatic setting.
Patients with brain metastases. Radiological imaging (e.g. CT or MRI scan) of the brain is required at screening/baseline
Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
Patients who have received the last administration of an anticancer targeted small molecule therapy ≤ 2 weeks prior to starting study treatment (e.g. sunitinib, pazopanib, axitinib, everolimus, temsirolimus), or who have not recovered from the side effects of such therapy
Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study treatment, or who have not recovered from the side effects of such therapy
Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months
Patients with concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Highlands Oncology Group Dept of Highlands Oncology Grp
University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)
Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC)
University of California at Los Angeles UCLA (4)
Stanford University Medical Center Cancer Clinical Trials Office
Rocky Mountain Cancer Centers RMCC
Florida Cancer Specialists DeptofFloridaCancerSpecialists
University Cancer & Blood Center, LLC
Straub Clinic & Hospital Straub
Moanalua Medical Center. Attn: Oncology Dept
University of Kansas Cancer Center Univ of KS
University of Maryland Medical Center UMMC
Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)
University of Minnesota Medical Center - Fairview Univ of MN
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
CINJ at Cooper University Hospital Cooper
Memorial Sloan Kettering Cancer Center Dept. of MSKCC
SUNY - Upstate Medical University Div. of Hematology-Oncology
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
Willamette Valley Clinical Studies Williamette Valley Cancer
St. Luke's Hospital and Health Network St Luke's
Medical University of South Carolina -Hollings Cancer Center Med Univ SC
Cancer Centers of the Carolinas CC of C -Eastside
Sarah Cannon Research Institute SC - 3
The West Clinic
Vanderbilt University Medical Center SC
Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (4)
Texas Oncology Texas Onc - Austin
Texas Oncology Texas Oncology - Houston
University of Texas Southwestern Medical Center UTSW
Deke Slayton Cancer Center Deke Slayton Cancer Center (2)
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
University of Virginia Health Systems Univ Virginia
Rockwood Clinic Spokane Location
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dovitinib + best supportive care (BSC)

Sorafenib + BSC

Arm Description

Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule.

Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Per Independent Central Radiology Review

Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.

Secondary Outcome Measures

Overall Survival (OS)

Overall survival (OS) was the key secondary endpoint and was defined as the time from date of randomization to the date of death due to any cause. If a patient was not known to have died, survival was censored on the date of last contact.

Progression Free Survival (PFS) Per Investigator's Radiology Review

PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. The primary analysis for PFS (based on central review) was also to be repeated on FAS considering the Investigator assessments and using the same analytical conventions as the primary analysis.

Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review

Overall response rate (ORR) was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). Best overall esponse (BOR) for each patient was determined from the sequence of overall (lesion) responses according to the following rules: CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. SD = at least one SD assessment (or better) > 6 weeks after randomization (and not qualifying for CR or PR). PD = progression ≤ 17 weeks after randomization (and not qualifying for CR, PR or SD).

Time to Definitive Worsening of Karnofsky Performance Status (KPS)

Time to definitive worsening of Karnofsky performance status (KPS) was defined as the time from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier. Definitive worsening was defined as a definitive decrease in performance status by at least one Karnofsky category (i.e. at least 10 points less) compared to Baseline. Worsening was considered definitive if no later increase above the defined threshold was observed within the course of the study. A single measure reporting a decrease in Karnofsky performance status was sufficient to consider it as definitive only if it was the last one available for this patient. Time to definitive worsening of KPS was analyzed at the time of the final analysis for PFS.

Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores

The Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) is a validated symptom scale used in studies of patients with kidney cancer. It includes 9-items that assess pain, bone pain, fatigue, lack of energy, shortness of breath, fevers, weight loss, coughing, and blood in urine and responses to each question are answered on a 5-point Likert-type scale ranging from 0 to 4 (e.g., 0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). FKSI-DRS scores range from 0 to 36, where higher scores correspond to better outcomes (eg, fewer symptoms).

Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%

The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.

Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%

Pre-dose Concentration in Plasma in Dovitinib

Predose concentrations of dovitinib were summarized by visit using PAS. All concentration data was listed by patient and time point using FAS. Mean pre-dose concentrations along with standard deviation (SD) was plotted over time if appropriate.

Full Information

NCT ID

NCT01223027

First Posted

September 30, 2010

Last Updated

November 5, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01223027

Brief Title

Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

Official Title

An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

6. Conditions and Keywords

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

Metastatic Renal Cell Carcinoma

Keywords

Dovitinib, TKI, Renal cell cancer, RCC, mRCC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

564 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dovitinib + best supportive care (BSC)

Arm Type

Experimental

Arm Description

Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule.

Arm Title

Sorafenib + BSC

Arm Type

Active Comparator

Arm Description

Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.

Intervention Type

Drug

Intervention Name(s)

Dovitinib

Other Intervention Name(s)

TKI258

Intervention Description

Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Intervention Description

Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS) Per Independent Central Radiology Review

Description

Time Frame

Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

until at least 386 deaths are documented in the clinical database.

Title

Progression Free Survival (PFS) Per Investigator's Radiology Review

Description

Time Frame

Until disease progression or discontinuation of treatment due to unacceptable toxicity

Title

Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review

Description

Time Frame

Until disease progression or discontinuation of treatment due to unacceptable toxicity

Title

Time to Definitive Worsening of Karnofsky Performance Status (KPS)

Description

Time Frame

from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier

Title

Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores

Description

Time Frame

from date of randomization, at least 2 score units

Title

Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%

Description

Time Frame

from date of randomization

Title

Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%

Description

Time Frame

from date of randomization

Title

Pre-dose Concentration in Plasma in Dovitinib

Description

Time Frame

Week 2 Day 5, Week 4 Day 5, Week 6 Day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell Patients must have received one and only one prior VEGF-targeted therapy and one and only one prior mTOR inhibitor therapy in the metastatic setting. One VEGF targeted therapy (e.g. sunitinib, or pazopanib, or axitinib, or tivozanib or bevacizumab) and one prior mTOR inhibitor therapy (everolimus, or temsirolimus or ridaforolimus) Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted. Patients must have had disease progression on or within 6 months of stopping the last therapy. Patients must have at least one measurable lesion at baseline (by RECIST Criteria Guidelines v1.1) assessed by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI). Karnofsky performance status ≥ 70% Patients must have the following laboratory values: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Hemoglobin (Hgb) > 9 g/dL Serum total bilirubin: ≤ 1.5 x ULN ALT and AST ≤ 3.0 x ULN (Patients with known liver metastases: AST and ALT ≤ 5.0 x ULN) Serum creatinine ≤ 1.5 x ULN Exclusion Criteria: Patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant or metastatic setting. Patients who have previously received Dovitinib or brivanib in the neoadjuvant, adjuvant or metastatic setting. Patients with brain metastases. Radiological imaging (e.g. CT or MRI scan) of the brain is required at screening/baseline Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix Patients who have received the last administration of an anticancer targeted small molecule therapy ≤ 2 weeks prior to starting study treatment (e.g. sunitinib, pazopanib, axitinib, everolimus, temsirolimus), or who have not recovered from the side effects of such therapy Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study treatment, or who have not recovered from the side effects of such therapy Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months Patients with concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study Other protocol-defined inclusion/exclusion criteria may apply

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

Highlands Oncology Group Dept of Highlands Oncology Grp

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)

City

La Jolla

State/Province

California

ZIP/Postal Code

92093-0658

Country

United States

Facility Name

Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

University of California at Los Angeles UCLA (4)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Stanford University Medical Center Cancer Clinical Trials Office

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Rocky Mountain Cancer Centers RMCC

City

Greenwood Village

State/Province

Colorado

Country

United States

Facility Name

Florida Cancer Specialists DeptofFloridaCancerSpecialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

University Cancer & Blood Center, LLC

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Straub Clinic & Hospital Straub

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Moanalua Medical Center. Attn: Oncology Dept

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Facility Name

University of Kansas Cancer Center Univ of KS

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

University of Maryland Medical Center UMMC

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

University of Minnesota Medical Center - Fairview Univ of MN

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

CINJ at Cooper University Hospital Cooper

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center Dept. of MSKCC

City

State/Province

New York

ZIP/Postal Code

90033

Country

United States

Facility Name

SUNY - Upstate Medical University Div. of Hematology-Oncology

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

City

Troy

State/Province

New York

ZIP/Postal Code

12180

Country

United States

Facility Name

Willamette Valley Clinical Studies Williamette Valley Cancer

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97404

Country

United States

Facility Name

St. Luke's Hospital and Health Network St Luke's

City

Bethlehem

State/Province

Pennsylvania

Country

United States

Facility Name

Medical University of South Carolina -Hollings Cancer Center Med Univ SC

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Cancer Centers of the Carolinas CC of C -Eastside

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Sarah Cannon Research Institute SC - 3

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

The West Clinic

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Vanderbilt University Medical Center SC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (4)

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Texas Oncology Texas Onc - Austin

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Facility Name

Texas Oncology Texas Oncology - Houston

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Facility Name

University of Texas Southwestern Medical Center UTSW

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9034

Country

United States

Facility Name

Deke Slayton Cancer Center Deke Slayton Cancer Center (2)

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

University of Virginia Health Systems Univ Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908-0334

Country

United States

Facility Name

Rockwood Clinic Spokane Location

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Sante Fe

ZIP/Postal Code

S200DSK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1050AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novartis Investigative Site

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Novartis Investigative Site

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Novartis Investigative Site

City

Footscray

State/Province

Victoria

ZIP/Postal Code

3011

Country

Australia

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90610-000

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 4E6

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

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

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

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 1N8

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Novartis Investigative Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Novartis Investigative Site

City

Bogota

Country

Colombia

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

656 53

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Besancon Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

33075

Country

France

Facility Name

Novartis Investigative Site

City

Caen Cedex

ZIP/Postal Code

14021

Country

France

Facility Name

Novartis Investigative Site

City

Clermont-Ferrand

ZIP/Postal Code

63011

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

Lyon Cedex

ZIP/Postal Code

69373

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Novartis Investigative Site

City

Nice Cedex 2

ZIP/Postal Code

06189

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Novartis Investigative Site

City

Rennes Cedex

ZIP/Postal Code

35062

Country

France

Facility Name

Novartis Investigative Site

City

Saint Priest en Jarez Cedex

ZIP/Postal Code

42271

Country

France

Facility Name

Novartis Investigative Site

City

Saint-Herblain Cédex

ZIP/Postal Code

44805

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg Cedex

ZIP/Postal Code

F-67098

Country

France

Facility Name

Novartis Investigative Site

City

Suresnes

ZIP/Postal Code

92150

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Vandoeuvre-Les-Nancy Cede

ZIP/Postal Code

54511

Country

France

Facility Name

Novartis Investigative Site

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10098

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09119

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

ZIP/Postal Code

90419

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Weiden

ZIP/Postal Code

92637

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

546 45

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 28

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1086

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

H-1122

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szolnok

ZIP/Postal Code

H-5000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

5266202

Country

Israel

Facility Name

Novartis Investigative Site

City

Zrifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Novartis Investigative Site

City

Arezzo

State/Province

ZIP/Postal Code

52100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cremona

State/Province

ZIP/Postal Code

26100

Country

Italy

Facility Name

Novartis Investigative Site

City

Meldola

State/Province

ZIP/Postal Code

47014

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Modena

State/Province

ZIP/Postal Code

41100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00152

Country

Italy

Facility Name

Novartis Investigative Site

City

Candiolo

State/Province

ZIP/Postal Code

10060

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80132

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Toon-city

State/Province

Ehime

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Hiroshima-city

State/Province

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Novartis Investigative Site

City

Obihiro

State/Province

Hokkaido

ZIP/Postal Code

080-0016

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Novartis Investigative Site

City

Kobe-city

State/Province

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Novartis Investigative Site

City

Kobe-city

State/Province

Hyogo

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

236 0037

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto-city

State/Province

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsumoto

State/Province

Nagano

ZIP/Postal Code

390-8621

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Novartis Investigative Site

City

OsakaSayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Suita-city

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Novartis Investigative Site

City

Takatsuki-city

State/Province

Osaka

ZIP/Postal Code

569-8686

Country

Japan

Facility Name

Novartis Investigative Site

City

Hidaka

State/Province

Saitama

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

Novartis Investigative Site

City

Kitaadachi-gun

State/Province

Saitama

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

Novartis Investigative Site

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Novartis Investigative Site

City

Koto

State/Province

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Novartis Investigative Site

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

105-8470

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

162-8666

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

537-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Yamagata

ZIP/Postal Code

990-9585

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

110 744

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Meerssen

State/Province

ZIP/Postal Code

6231

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Dordrecht

ZIP/Postal Code

3318AT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

-N5021

Country

Norway

Facility Name

Novartis Investigative Site

City

Ålesund

ZIP/Postal Code

NO-6026

Country

Norway

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Novartis Investigative Site

City

Riyadh

ZIP/Postal Code

11211

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

83310

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41014

Country

Spain

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33006

Country

Spain

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de LLobregat

State/Province

Catalunya

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Benidorm

State/Province

Comunidad Valenciana

ZIP/Postal Code

03501

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46009

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma De Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07120

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canarias

State/Province

Las Palmas de Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

Novartis Investigative Site

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

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

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

Novartis Investigative Site

City

Sundsvall

ZIP/Postal Code

851 86

Country

Sweden

Facility Name

Novartis Investigative Site

City

Umeå

ZIP/Postal Code

SE-901 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bristol

State/Province

Avon

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Colchester

ZIP/Postal Code

CO3 3NB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 4QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M20 9BX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24556040

Citation

Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grunwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96. doi: 10.1016/S1470-2045(14)70030-0. Epub 2014 Feb 17.

Results Reference

derived

Learn more about this trial

Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

We'll reach out to this number within 24 hrs