Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Lenalidomide; Sunitinib; Thalidomide

Criteria

Inclusion Criteria:

1. Metastatic Renal Cell Carcinoma.

2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

Exclusion Criteria:

1. Prior chemotherapy.

2. Prior treatment with lenalidomide, thalidomide, pomalidomide, or sunitinib.

3. Laboratory values outside normal ranges.

4. Myocardial infarction (MI) within past 12 months.

5. Current congestive heart failure.