Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma (RECORD-3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00903175
First received: April 24, 2009
Last updated: May 20, 2016
Last verified: May 2016
  Purpose
This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.

Condition Intervention Phase
Renal Cell Carcinoma
Drug: everolimus
Drug: sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of RAD001 as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line RAD001 in the Treatment of Patients With Metastatic Renal Cell Carcinoma.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival First-Line (PFS 1-L) [ Time Frame: Time from randomization to date of first disease progression or death during or after 1-L treatment, or last tumor assessment, reported between date of 1st participant randomized until 03-sep-2012, cutoff date (i.e. when 340 PFS-1L events were observed) ] [ Designated as safety issue: No ]
    PFS_1L based on investigator assessment of radiology data by RECIST 1.0, 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 during or after first-line treatment with everolimus or sunitinib. Radiological assessments : every 12 weeks until disease progression, the start of another antineoplastic therapy or for any other reason.


Secondary Outcome Measures:
  • Progression-free Survival Combined (PFS-C) [ Time Frame: Time from randomization to date of 1st disease progression during or after 2-L treatment or date of death, or last tumor assessment, reported between date of 1st participant randomized until 3 years after last patient randomized (date cutoff : 16Jun2014) ] [ Designated as safety issue: No ]
    PFS-C (1L and 2L study drugs combined) was a composite endpoint which combined both lines of study treatment. It was defined as the time from the date of randomization to the first of the following: date of death due to any cause, or date of the first radiologically documented progression disease during or after the second-line treatment period for patients with a radiologically documented progression disease in the first-line treatment period and who had crossed-over to second-line treatment no more than 6 weeks after progression. Radiological assessments : every 12 weeks until disease progression, the start of another antineoplastic therapy or for any other reason.

  • Overall Survival (OS) [ Time Frame: Time from randomization to the date of death from any cause, reported between the date of first participant randomized and up to 3 years after the last participant randomized (date cutoff: 16Jun2014) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from date of randomization to date of death due to any cause. The analysis of OS included all deaths in the FAS regardless of when they were observed.

  • Overall Response Rate (ORR) - First -Line (1-L) [ Time Frame: time from first participant randomized until 03-sep-2012, cutoff date ] [ Designated as safety issue: No ]
    ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) and was based on investigator assessment of radiology data per RECIST. Participants with best overall response of 'Unknown' were treated as non-responders in the calculation of the ORR. 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. Radiological assessments : every 12 weeks until disease progression, the start of another antineoplastic therapy or for any other reason.

  • Duration of Response (DoR) - First-Line (1-L) [ Time Frame: Time from first documented response date to date of disease progression, death from any cause during or after the 1-L period or last tumor assessment, reported between the date of first participant randomized until 03-sep-2012, cut-off date ] [ Designated as safety issue: No ]
    Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR) during the first-line treatment period. The start date was the date of first documented response (CR or PR) during the first-line treatment and the end date was the date of the event defined as the first documented progression or death due to underlying cancer during or after the same treatment line.

  • Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First-line Drug [ Time Frame: Time from randomization to date of definitive deterioration (defined as no later increase above threshold observed during the 1-L period), or date of last assessment, reported between date of first patient randomized until 03-sep-2012, cutoff date) ] [ Designated as safety issue: No ]
    The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L of treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient. PRO questionnaires were to be completed on day 1, day 28 of every cycle, at the end of treatment visit, at the 28-day FUP visit, and monthly thereafter for up to 3 months or until the initiation of another anticancer therapy.

  • Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First and Second-line Drugs Combined [ Time Frame: Time from randomization to date of definitive deterioration (defined as no later increase above threshold observed during the 1-L or 2-L period), or date of last assessment, reported between date of first patient randomized until 03-sep-2012, cutoff date) ] [ Designated as safety issue: No ]
    The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L or 2-L treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient. PRO questionnaires were to be completed on day 1, day 28 of every cycle, at the end of treatment visit, at the 28-day FUP visit, and monthly thereafter for up to 3 months or until the initiation of another anticancer therapy.

  • Time to Definitive Deterioration of the Physical Functioning (PF) Scale of the EORTC QLQ-C30 - by First-Line (1L) Drug [ Time Frame: Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the 1-L period), or date of last assessment, reported between date of first patient randomized until 03-sep-2012, cutoff date ] [ Designated as safety issue: No ]
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.

  • Time to Definitive Deterioration of the Physical Functioning Scale of the EORTC QLQ-C30 - by First and Second-Line Drugs Combined [ Time Frame: Time from randomization to date of definitive deterioration (defined as no later increase above threshold observed during the 1-L or 2-L period), or date of last assessment, reported between date of 1st patient randomized until 03-sep-2012, cutoff date ] [ Designated as safety issue: No ]
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.

  • Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First-Line Drug [ Time Frame: Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the 1-L period), or date of last assessment, reported between date of first patient randomized until 03-sep-2012, cutoff date ] [ Designated as safety issue: No ]
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.

  • Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First and Second-Line Drugs Combined [ Time Frame: Time from randomization to date of definitive deterioration (defined as no later increase above threshold observed during the 1-L or 2-L period), or date of last assessment, reported between dates of 1st patient randomized until 03-sep-2012, cutoff date ] [ Designated as safety issue: No ]
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.

  • Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First-Line Drug [ Time Frame: Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the 1-L period), or date of last assessment, reported between date of first patient randomized until 03-sep-2012, cutoff date ] [ Designated as safety issue: No ]
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.

  • Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First and Second-Line Drugs Combined [ Time Frame: Time from randomization to date of definitive deterioration (defined as no later increase above threshold observed during the 1-L or 2-L period), or date of last assessment, reported between date of 1st patient randomized until 03-sep-2012, cutoff date ] [ Designated as safety issue: No ]
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.


Enrollment: 471
Study Start Date: October 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus 1L/sunitinib 2L
everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
Drug: everolimus
Everolimus was administered orally at 10 mg/day. Everolimus is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. The
Other Name: RAD001
Drug: sunitinib
Sunitinib was administered orally 50 mg daily, on a schedule of 4 weeks on/2 weeks off. Sunitinib was supplied as hard gelatin capsules of 12.5 mg, 25 mg, or 50 mg strength according to local practice.
Active Comparator: sunitinib 1L/everolimus 2L
sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
Drug: everolimus
Everolimus was administered orally at 10 mg/day. Everolimus is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. The
Other Name: RAD001
Drug: sunitinib
Sunitinib was administered orally 50 mg daily, on a schedule of 4 weeks on/2 weeks off. Sunitinib was supplied as hard gelatin capsules of 12.5 mg, 25 mg, or 50 mg strength according to local practice.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with advanced renal cell carcinoma.
  2. Patients with at least one measurable lesion.
  3. Patients with a Karnofsky Performance Status ≥70%.
  4. Adequate bone marrow function.
  5. Adequate liver function.
  6. Adequate renal function.
  7. Left ventricular ejection fraction (LVEF) ≥ lower limit of institutional normal (LLN)
  8. Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of the study medication. Adequate contraception must be used while on study.

Exclusion Criteria:

  1. Less than 4 weeks post-major surgery
  2. Patients who had radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed within 2 weeks prior to study treatment start).
  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 have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus) or VEGF inhibitors. Note: History of adjuvant immunotherapy, vaccines or adjuvant sorafenib following localized surgical nephrectomy is acceptable.
  8. Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins or to its excipients
  9. Patients with a known hypersensitivity to sunitinib or its excipients
  10. History or clinical evidence of central nervous system (CNS) metastases. Note: Subjects who have previously-treated CNS metastases (surgery plus or minus radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:

    • Are asymptomatic and,
    • have had no evidence of active CNS metastases for ≥ 6 months prior to enrollment and,
    • have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC)
  11. Clinically significant gastrointestinal abnormalities including, but not limited to:

    • Malabsorption syndrome
    • Major resection of the stomach or small bowel that could affect the absorption of study drug
    • Active peptic ulcer disease
    • Inflammatory bowel disease
    • Ulcerative colitis, 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.
  12. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥160mmHg or diastolic blood pressure (DBP) of ≥ 95mmHg]
  13. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent
  14. Patients with a known history of HIV seropositivity.
  15. Patients with active bleeding.
  16. Patients who have any severe and/or uncontrolled medical conditions or other conditions within the past 12 months that could affect their participation in the study such as:

    • Cardiac angioplasty or stenting, unstable angina pectoris, symptomatic peripheral vascular disease, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia, cerebrovascular accidents ≤ 6 months before study treatment start.
    • Prolongation of corrected QT interval (QTc) > 500 milliseconds (msecs).
    • Severally impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 0^2 saturation that is 88% or less at rest on room air.
    • Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN.
    • Any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study.
    • Liver disease such as chronic active hepatitis or chronic persistent hepatitis.
  17. History of cerebrovascular accident (CVA) including transient ischemic attack (TIA).
  18. History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
  19. Patients who have a history of another primary malignancy and off treatment for ≤ 3 years
  20. Female patients of child-bearing potential who are not using adequate birth control methods, or who are pregnant or breast feeding.
  21. Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
  22. Patients unwilling or unable to comply with the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903175

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham/ Kirklin Clinic Comprehensive CancerCenter (1)
Birmingham, Alabama, United States, 35294-0006
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
Mobile, Alabama, United States, 36688
United States, Arkansas
Highlands Oncology Group HighlandsOncGrp-Bentonville(2)
Fayetteville, Arkansas, United States, 72703
United States, California
University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)
La Jolla, California, United States, 92093-0658
University of California at Los Angeles Dept. of UCLA (3)
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Dept. of Anschutz Cancer (2)
Aurora, Colorado, United States, 80045
United States, Connecticut
Norwalk Hospital Norwlak SC
Norwalk, Connecticut, United States, 06856
United States, District of Columbia
Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Ctr (2
Washington, District of Columbia, United States, 20007-2197
United States, Florida
Lynn Cancer Institute
Boca Raton, Florida, United States, 33486
University of Miami SC
Miami, Florida, United States, 33136
MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando
Orlando, Florida, United States, 32806
United States, Georgia
University Cancer & Blood Center, LLC Dept of NE GCC (2)
Athens, Georgia, United States, 30607
Georgia Health Sciences University Dept. of MCG
Augusta, Georgia, United States, 30912
Summit Cancer Care
Savannah, Georgia, United States, 31405
United States, Illinois
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept.ofNorthwesternMemHospital
Chicago, Illinois, United States, 60611
Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3)
Maywood, Illinois, United States, 60153
United States, Louisiana
Crescent City Research Consortium, LLC SC
Metairie, Louisiana, United States, 70006
United States, Maryland
VA Maryland Health Care Dept.of GreenbaumCancerCent(7)
Baltimore, Maryland, United States, 21201
Weinberg Cancer Institute at Franklin Square Hospital
Baltimore, Maryland, United States, 21237-3998
United States, Montana
Billings Clinic Dept of Billings Clinic(2)
Billings, Montana, United States, 59107
United States, New Jersey
Hackensack University Medical Center DeptofHackensackUniv.MedCtr.
Hackensack, New Jersey, United States, 07601
Cooper Cancer Center
Voorhees, New Jersey, United States, 08043
United States, New York
Clinical Research Alliance
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Cancer Center Dept. of MSKCC
NY, New York, United States, 90033
SUNY - Upstate Medical University Div. of Hematology-Oncology
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina Dept. of LinbergerCancerCtr(3)
Chapel Hill, North Carolina, United States, 27599-7295
Levine Cancer Institute Oncology
Charlotte, North Carolina, United States, 28203
Duke University Medical Center Duke
Durham, North Carolina, United States, 27710
United States, Oklahoma
University of Oklahoma Health Sciences Center Dept of OHSC
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
St. Luke's Hospital and Health Network St Luke's Hospital (2)
Bethlehem, Pennsylvania, United States, 18015
United States, Tennessee
The West Clinic Dept. of the West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)
Fort Worth, Texas, United States, 76104
East Texas Medical Center Cancer Institute
Tyler, Texas, United States, 75701
United States, Utah
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
Salt Lake City, Utah, United States, 84106
United States, Wisconsin
Aurora Advanced Healthcare SC
Milwaukee, Wisconsin, United States, 53215
Argentina
Novartis Investigative Site
La Plata, Buenos Aires, Argentina, B1902CMK
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2002KDS
Novartis Investigative Site
Buenos Aires, Argentina, C1405BCH
Novartis Investigative Site
Tucuman, Argentina, T4000IAK
Australia, South Australia
Novartis Investigative Site
Woodville, South Australia, Australia, 5011
Brazil
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 20230-130
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site
Sao Paulo, SP, Brazil, 05403-000
Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 4N2
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 4E6
Novartis Investigative Site
Victoria, British Columbia, Canada, V8R 6V5
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M4N 3M5
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2H1
Novartis Investigative Site
Montreal, Quebec, Canada, H2X 3J4
Canada, Saskatchewan
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada, S7N 4H4
Denmark
Novartis Investigative Site
Herlev, Denmark, DK-2730
France
Novartis Investigative Site
Angers cedex 02, France, 49055
Novartis Investigative Site
Lille Cedex, France, 59020
Novartis Investigative Site
Paris, France, 75015
Novartis Investigative Site
Vandoeuvre-Les-Nancy Cede, France, 54511
Germany
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Weiden, Germany, 92637
Hong Kong
Novartis Investigative Site
Hongkong, Hong Kong
Novartis Investigative Site
Shatin, New Territories, Hong Kong
Italy
Novartis Investigative Site
Arezzo, AR, Italy, 52100
Novartis Investigative Site
Modena, MO, Italy, 41100
Novartis Investigative Site
Napoli, Italy, 80132
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 03080
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 03722
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 05505
Novartis Investigative Site
Daejeon, Korea, Republic of, 301-747
Mexico
Novartis Investigative Site
Chihuahua, Mexico, 31000
Netherlands
Novartis Investigative Site
Den Haag, Netherlands, 2545 CH
Novartis Investigative Site
Maastricht, Netherlands, 6229 HX
Peru
Novartis Investigative Site
Jesus Maria, Lima, Peru, 11
Spain
Novartis Investigative Site
Elche, Alicante, Spain, 03203
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site
Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site
Lleida, Cataluna, Spain, 25198
Taiwan
Novartis Investigative Site
Taipei, Taiwan, ROC, Taiwan, 112
Novartis Investigative Site
Niaosong Township, Taiwan, 83301
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10700
Turkey
Novartis Investigative Site
Istanbul, Turkey, 34093
United Kingdom
Novartis Investigative Site
Bristol, Avon, United Kingdom, BS2 8ED
Novartis Investigative Site
London, United Kingdom, SW3 6JJ
Novartis Investigative Site
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00903175     History of Changes
Other Study ID Numbers: CRAD001L2202  2009-011056-21 
Study First Received: April 24, 2009
Results First Received: May 20, 2016
Last Updated: May 20, 2016
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
France: Ministry of Health
Germany: Ministry of Health
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Spain: Ministry of Health

Keywords provided by Novartis:
RAD001
everolimus
sunitinib
renal cell carcinoma
kidney cancer
metastatic renal cell cancer
advanced kidney cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 30, 2016