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

Phase 1: Maximum Tolerated Dose (MTD)

时间窗: Within 21 days of first dose of treatment

The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were: • Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in: * Grade (GR) 3 or 4 non-hematological toxicity lasting for ≥ 14 days * Febrile neutropenia * Gr 4 neutropenia lasting for ≥ 7 days * Gr 4 thrombocytopenia The occurrence of one of the above drug-related toxicities resulting in a clinical and/or laboratory assessment being done within 7 days following the initial finding to examine the participants for resolution of the toxicity. Lack of resolution of the toxicities was considered a DLT. If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation.

Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

时间窗: After at least 3 cycles of treatment

Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria: * Complete response-disappearance of all lesions * Partial response-30% decrease in the sum of diameters of target lesions from baseline * Stable disease-neither shrinkage nor increase of lesions. * Progressive Disease-20% increase in the sum of diameters of target lesions from nadir.