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Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

Primary Purpose

Carcinoma, Adenocarcinoma, Renal Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RAD001(everolimus)
interferon alfa-2a
bevacizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring Renal cell carcinoma, Adults, Bevacizumab, RAD001, Everolimus, Interferon, Clear, Roferon, Avastin, Nephrectomy, newly diagnosed

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with metastatic renal cell carcinoma
  2. Patients with at least one measurable lesion
  3. Patients with progressive metastatic renal cell carcinoma
  4. Patients who had a prior partial or complete nephrectomy
  5. Patients with a Karnofsky Performance Status ≥70%.
  6. Adequate bone marrow function
  7. Adequate liver function
  8. Adequate renal function
  9. Adequate coagulation profile

Exclusion Criteria:

  1. 4 weeks post-major surgery
  2. Patients who had radiation therapy within 28 days prior to start of study
  3. Patients in need for major surgical procedure during the course of the study.
  4. Patients with a serious non-healing wound, ulcer, or bone fracture.
  5. Patients with a history of seizure(s) not controlled with standard medical therapy.
  6. Patients who have received prior systemic treatment for their metastatic RCC.
  7. Patients who received prior therapy with VEGF pathway inhibitor
  8. Patients who have previously received systemic mTOR inhibitors
  9. Patients with a known hypersensitivity RAD001 (everolimus) or other rapamycins or to its excipients.
  10. Patients with history or current central nervous system (CNS) metastases or spinal cord compression.
  11. Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
  12. Patients with proteinuria at screening.
  13. Patients with inadequately controlled hypertension
  14. Patients receiving ongoing or with recent need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin
  15. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
  16. Patients with a known history of HIV
  17. Patients with hypersensitivity to interferon alfa-2a or any component of the product.
  18. Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism
  19. Patients who have any severe and/or uncontrolled medical conditions or other conditions
  20. Left Ventricular Ejection Fraction < lower limit of institutional normal assessed by ECHO or MUGA
  21. Patients who have a history of another primary malignancy ≤ 3 years
  22. Female patients who are pregnant or breast feeding
  23. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
  24. Patients unwilling to or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Highlands Oncology Group Dept of Highlands Oncology Grp
  • City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)
  • USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
  • University of California at Los Angeles Dept. of Hem/Oncology
  • Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)
  • Nevada Cancer Institute Dept. of Nevada Cancer (3)
  • St. Luke's Hospital and Health Network St. Luke's Cancer Network
  • Las Colinas Hematology Oncology Grapevine
  • Seattle Cancer Care Alliance Dept. of SCCA
  • Novartis Investigative Site
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bevacizumab, RAD001 (everolimus)

bevacizumab, interferon alfa-2a (IFN)

Arm Description

Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks

Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.

Secondary Outcome Measures

Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths
Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.
Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units
The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.
Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%
The EORTC QLQ-C30 contains 30 items. 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). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.
Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab
This outcome measure was assessed continuously.

Full Information

First Posted
July 15, 2008
Last Updated
February 13, 2017
Sponsor
Novartis Pharmaceuticals
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00719264
Brief Title
Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
Official Title
A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 12, 2008 (Actual)
Primary Completion Date
December 31, 2011 (Actual)
Study Completion Date
April 15, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Roche Pharma AG

4. Oversight

5. Study Description

Brief Summary
To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Adenocarcinoma, Renal Cell, Nephroid Carcinoma, Hypernephroid
Keywords
Renal cell carcinoma, Adults, Bevacizumab, RAD001, Everolimus, Interferon, Clear, Roferon, Avastin, Nephrectomy, newly diagnosed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab, RAD001 (everolimus)
Arm Type
Experimental
Arm Description
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks
Arm Title
bevacizumab, interferon alfa-2a (IFN)
Arm Type
Active Comparator
Arm Description
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks
Intervention Type
Drug
Intervention Name(s)
RAD001(everolimus)
Other Intervention Name(s)
Afinitor
Intervention Description
10 mg qd
Intervention Type
Drug
Intervention Name(s)
interferon alfa-2a
Intervention Description
dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
10 mg/kg every 2 weeks
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Description
Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Time Frame
Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.
Secondary Outcome Measure Information:
Title
Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Description
Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.
Time Frame
Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)
Title
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Description
Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Time Frame
Time from first participant randomized until 31Dec2011, cutoff date.
Title
Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Description
The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.
Time Frame
Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.
Title
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths
Description
Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.
Time Frame
From the first participant randomized until the last patient discontinued the study treatment + 28 days
Title
Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units
Description
The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.
Time Frame
Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011
Title
Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%
Description
The EORTC QLQ-C30 contains 30 items. 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). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.
Time Frame
Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011
Title
Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab
Description
This outcome measure was assessed continuously.
Time Frame
From the date of the first participant treated until the last patient discontinued the study treatment + 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with metastatic renal cell carcinoma Patients with at least one measurable lesion Patients with progressive metastatic renal cell carcinoma Patients who had a prior partial or complete nephrectomy Patients with a Karnofsky Performance Status ≥70%. Adequate bone marrow function Adequate liver function Adequate renal function Adequate coagulation profile Exclusion Criteria: 4 weeks post-major surgery Patients who had radiation therapy within 28 days prior to start of study Patients in need for major surgical procedure during the course of the study. Patients with a serious non-healing wound, ulcer, or bone fracture. Patients with a history of seizure(s) not controlled with standard medical therapy. Patients who have received prior systemic treatment for their metastatic RCC. Patients who received prior therapy with VEGF pathway inhibitor Patients who have previously received systemic mTOR inhibitors Patients with a known hypersensitivity RAD001 (everolimus) or other rapamycins or to its excipients. Patients with history or current central nervous system (CNS) metastases or spinal cord compression. Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment. Patients with proteinuria at screening. Patients with inadequately controlled hypertension Patients receiving ongoing or with recent need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent. Patients with a known history of HIV Patients with hypersensitivity to interferon alfa-2a or any component of the product. Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism Patients who have any severe and/or uncontrolled medical conditions or other conditions Left Ventricular Ejection Fraction < lower limit of institutional normal assessed by ECHO or MUGA Patients who have a history of another primary malignancy ≤ 3 years Female patients who are pregnant or breast feeding Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start. Patients unwilling to or unable to comply with the protocol 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
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
City
Los Angeles
State/Province
California
ZIP/Postal Code
90053
Country
United States
Facility Name
University of California at Los Angeles Dept. of Hem/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
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
Nevada Cancer Institute Dept. of Nevada Cancer (3)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
St. Luke's Hospital and Health Network St. Luke's Cancer Network
City
Bethlehem
State/Province
Pennsylvania
Country
United States
Facility Name
Las Colinas Hematology Oncology Grapevine
City
Irving
State/Province
Texas
ZIP/Postal Code
75038
Country
United States
Facility Name
Seattle Cancer Care Alliance Dept. of SCCA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novartis Investigative Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90560-030
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14015-130
Country
Brazil
Facility Name
Novartis Investigative Site
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Prague
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Cairo
Country
Egypt
Facility Name
Novartis Investigative Site
City
Strasbourg
State/Province
Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Novartis Investigative Site
City
Avignon
ZIP/Postal Code
84000
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
La Roche sur Yon Cedex
ZIP/Postal Code
85925
Country
France
Facility Name
Novartis Investigative Site
City
Montellier cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Novartis Investigative Site
City
Nantes cedex 2
ZIP/Postal Code
44202
Country
France
Facility Name
Novartis Investigative Site
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Novartis Investigative Site
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg Cedex
ZIP/Postal Code
67010
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
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Novartis Investigative Site
City
Dessau
ZIP/Postal Code
06846
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Göttingen
ZIP/Postal Code
37075
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
69115
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Novartis Investigative Site
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Tuen Mun
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1086
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Novartis Investigative Site
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Name
Novartis Investigative Site
City
Cremona
State/Province
CR
ZIP/Postal Code
26100
Country
Italy
Facility Name
Novartis Investigative Site
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41100
Country
Italy
Facility Name
Novartis Investigative Site
City
Perugia
State/Province
PG
ZIP/Postal Code
06129
Country
Italy
Facility Name
Novartis Investigative Site
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00152
Country
Italy
Facility Name
Novartis Investigative Site
City
Trento
State/Province
TN
ZIP/Postal Code
38100
Country
Italy
Facility Name
Novartis Investigative Site
City
Negrar
State/Province
VR
ZIP/Postal Code
37024
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novartis Investigative Site
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
03722
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
Daegu
ZIP/Postal Code
705-703
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
Taegu
ZIP/Postal Code
700 -721
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Obninsk
State/Province
Russia
ZIP/Postal Code
249036
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
125284
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
258500
Country
Singapore
Facility Name
Novartis Investigative Site
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0044
Country
South Africa
Facility Name
Novartis Investigative Site
City
Jaen
State/Province
Andalucía
ZIP/Postal Code
23007
Country
Spain
Facility Name
Novartis Investigative Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
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
28034
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Novartis Investigative Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Taipei
State/Province
Taiwan, ROC
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Lin-Kou
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novartis Investigative Site
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Novartis Investigative Site
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Novartis Investigative Site
City
Altunizade
ZIP/Postal Code
34662
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Novartis Investigative Site
City
Balcova / Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Novartis Investigative Site
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mecidiyekoy/Istanbul
ZIP/Postal Code
34394
Country
Turkey
Facility Name
Novartis Investigative Site
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Glasgow
ZIP/Postal Code
G12 0YN
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
25851632
Citation
Ravaud A, Barrios CH, Alekseev B, Tay MH, Agarwala SS, Yalcin S, Lin CC, Roman L, Shkolnik M, Anak O, Gogov S, Pelov D, Louveau AL, Melichar B. RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon alpha-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2015 Jul;26(7):1378-84. doi: 10.1093/annonc/mdv170. Epub 2015 Apr 7.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com/webapp/etrials/searchTrial.do?t=i&trialID=688
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Learn more about this trial

Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

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