Status:
COMPLETED
Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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:
- 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.
- History of cerebrovascular accident (CVA) including transient ischemic attack (TIA).
- 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.
- Patients who have a history of another primary malignancy and off treatment for ≤ 3 years
- Female patients of child-bearing potential who are not using adequate birth control methods, or who are pregnant or breast feeding.
- Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
- Patients unwilling or unable to comply with the protocol.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
471 Patients enrolled
Trial Details
Trial ID
NCT00903175
Start Date
October 1 2009
End Date
May 1 2015
Last Update
November 8 2016
Active Locations (84)
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1
University of Alabama at Birmingham/ Kirklin Clinic Comprehensive CancerCenter (1)
Birmingham, Alabama, United States, 35294-0006
2
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
Mobile, Alabama, United States, 36688
3
Highlands Oncology Group HighlandsOncGrp-Bentonville(2)
Fayetteville, Arkansas, United States, 72703
4
University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)
La Jolla, California, United States, 92093-0658