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

Completed · Phase 2

Conditions studied: Carcinoma, Adenocarcinoma, Renal Cell, Nephroid Carcinoma, Hypernephroid

In brief

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.

Key facts

Study ID

NCT00719264

Run by

Novartis Pharmaceuticals

People needed

365

Starts

2008-11-12

Expected to finish

2013-04-15

Last updated by the study team

2017-03-20

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3) — Duarte, California, United States
• USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3 — Los Angeles, California, United States
• University of California at Los Angeles Dept. of Hem/Oncology — Los Angeles, California, United States
• Karmanos Cancer Institute Dept.of KarmanosCancerInst (5) — Detroit, Michigan, United States
• Nevada Cancer Institute Dept. of Nevada Cancer (3) — Las Vegas, Nevada, United States
• St. Luke's Hospital and Health Network St. Luke's Cancer Network — Bethlehem, Pennsylvania, United States
• Las Colinas Hematology Oncology Grapevine — Irving, Texas, United States
• Seattle Cancer Care Alliance Dept. of SCCA — Seattle, Washington, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Charleroi, Belgium
• Novartis Investigative Site — Kortrijk, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Ribeirão Preto, São Paulo, Brazil
• Novartis Investigative Site — Santo André, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Olomouc, Czechia
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Cairo, Egypt, Egypt
• Novartis Investigative Site — Cairo, Egypt
• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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