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

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00903175

Run by

Novartis Pharmaceuticals

People needed

471

Starts

2009-10-01

Expected to finish

2015-05-01

Last updated by the study team

2016-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with advanced renal cell carcinoma.
• Patients with at least one measurable lesion.
• Patients with a Karnofsky Performance Status ≥70%.
• Adequate bone marrow function.
• Adequate liver function.
• Adequate renal function.
• Left ventricular ejection fraction (LVEF) ≥ lower limit of institutional normal (LLN)
• 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.

You may not qualify if…

• Less than 4 weeks post-major surgery
• 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).
• 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 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.
• 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
• Patients with a known hypersensitivity to sunitinib or its excipients
• 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)
• 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.
• Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥160mmHg or diastolic blood pressure (DBP) of ≥ 95mmHg]
• Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent
• Patients with a known history of HIV seropositivity.
• Patients with active bleeding.
• 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:

Where it is running

• University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst. — Mobile, Alabama, United States
• Highlands Oncology Group HighlandsOncGrp-Bentonville(2) — Fayetteville, Arkansas, United States
• University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5) — La Jolla, California, United States
• University of California at Los Angeles Dept. of UCLA (3) — Los Angeles, California, United States
• University of Colorado Dept. of Anschutz Cancer (2) — Aurora, Colorado, United States
• Norwalk Hospital Norwlak SC — Norwalk, Connecticut, United States
• Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Ctr (2 — Washington D.C., District of Columbia, United States
• Lynn Cancer Institute — Boca Raton, Florida, United States
• University of Miami SC — Miami, Florida, United States
• MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando — Orlando, Florida, United States
• University Cancer & Blood Center, LLC Dept of NE GCC (2) — Athens, Georgia, United States
• Georgia Health Sciences University Dept. of MCG — Augusta, Georgia, United States
• Summit Cancer Care — Savannah, Georgia, United States
• NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept.ofNorthwesternMemHospital — Chicago, Illinois, United States
• Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3) — Maywood, Illinois, United States
• Crescent City Research Consortium, LLC SC — Metairie, Louisiana, United States
• VA Maryland Health Care Dept.of GreenbaumCancerCent(7) — Baltimore, Maryland, United States
• Weinberg Cancer Institute at Franklin Square Hospital — Baltimore, Maryland, United States
• Billings Clinic Dept of Billings Clinic(2) — Billings, Montana, United States
• Hackensack University Medical Center DeptofHackensackUniv.MedCtr. — Hackensack, New Jersey, United States
• Cooper Cancer Center — Voorhees Township, New Jersey, United States
• Clinical Research Alliance — Lake Success, New York, United States
• Memorial Sloan Kettering Cancer Center Dept. of MSKCC — New York, New York, United States
• SUNY - Upstate Medical University Div. of Hematology-Oncology — Syracuse, New York, United States
• University of Alabama at Birmingham/ Kirklin Clinic Comprehensive CancerCenter (1) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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