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A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell, Adenocarcinoma, Renal Cell, Nephroid Carcinoma, Carcinoma, Hypernephroid

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Trial Information

A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney

Inclusion Criteria:

1. Patients with metastatic renal cell carcinoma

2. Patients with at least one measurable lesion

3. Patients with progressive metastatic renal cell carcinoma

4. Patients who had a prior partial or complete nephrectomy

5. Patients with a Karnofsky Performance Status ≥70%.

6. Adequate bone marrow function

7. Adequate liver function

8. Adequate renal function

9. Adequate coagulation profile

Exclusion Criteria:

1. 4 weeks post-major surgery

2. Patients who had radiation therapy within 28 days prior to start of study

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 received prior therapy with VEGF pathway inhibitor

8. Patients who have previously received systemic mTOR inhibitors

9. Patients with a known hypersensitivity RAD001 (everolimus) or other rapamycins or to
its excipients.

10. Patients with history or current central nervous system (CNS) metastases or spinal
cord compression.

11. Patients with a history of abdominal fistula, gastrointestinal perforation, or
intra-abdominal abscess within 6 months prior to study enrollment.

12. Patients with proteinuria at screening.

13. Patients with inadequately controlled hypertension

14. Patients receiving ongoing or with recent need for full therapeutic dose of oral or
parenteral anticoagulants or chronic daily treatment with aspirin

15. Patients receiving chronic systemic treatment with corticosteroids or another
immunosuppressive agent.

16. Patients with a known history of HIV

17. Patients with hypersensitivity to interferon alfa-2a or any component of the product.

18. Patients with an active, bleeding diathesis or coagulopathy or recurrent

19. Patients who have any severe and/or uncontrolled medical conditions or other

20. Left Ventricular Ejection Fraction < lower limit of institutional normal assessed by

21. Patients who have a history of another primary malignancy ≤ 3 years

22. Female patients who are pregnant or breast feeding

23. Patients who are using other investigational agents or who had received
investigational drugs ≤ 4 weeks prior to study treatment start.

24. Patients unwilling to or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) of patients who receive RAD001 plus bevacizumab versus patients who receive IFN plus bevacizumab based on an estimation of the chance of success of a possible subsequent phase III study

Outcome Description:

progression by central review, but anticancer treatment by clinical database (thru Case Report Form). Timeframe determined by central review.

Outcome Time Frame:

Every 12 weeks until progressive disease as per independent central review or the initiation of a new secondary anti-cancer therapy until 200 PFS events are observed

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

April 2013

Related Keywords:

  • Carcinoma, Renal Cell
  • Adenocarcinoma, Renal Cell
  • Nephroid Carcinoma
  • Carcinoma, Hypernephroid
  • Renal cell carcinoma,
  • Adults,
  • Bevacizumab,
  • RAD001
  • Everolimus,
  • Interferon
  • Clear
  • Roferon
  • Avastin
  • Nephrectomy
  • newly diagnosed
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Renal Cell



Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
Nevada Cancer Institute Dept. of Nevada Cancer (3)Las Vegas, Nevada  89135
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3Los Angeles, California  90053
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)Detroit, Michigan  48201
St. Luke's Hospital and Health Network St. Luke's Cancer NetworkBethlehem, Pennsylvania  
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)Duarte, California  91010-3000
University of California at Los Angeles Dept. of Hem/OncologyLos Angeles, California  90095
Las Colinas Hematology Oncology GrapevineIrving, Texas  75038
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Dept. of SCCASeattle, Washington  98109-1023