Status:
COMPLETED
Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Carcinoma
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 12 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2013
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT00719264
Start Date
November 12 2008
End Date
April 15 2013
Last Update
March 20 2017
Active Locations (109)
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1
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
2
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)
Duarte, California, United States, 91010-3000
3
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
Los Angeles, California, United States, 90053
4
University of California at Los Angeles Dept. of Hem/Oncology
Los Angeles, California, United States, 90095