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

A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Lenalidomide in Combination With Sunitinib in Subjects With Advanced or Metastatic Renal Cell Carcinoma

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.

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.