Conditions: Renal Cell Carcinoma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received an oral dose of lenalidomide MTD (mg) capsule administered in combination with a single dose of sunitinib 37.5 mg on days 1-21 of each 21-day cycle arm 2: Participants received an oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib 37.5 mg on days 1 to 14 or days 1 to 21 of each 21-day cycle

Interventions: intervention 1: Lenalidomide intervention 2: Sunitinib
Intervention descriptions: intervention 1: Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination intervention 2: Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G

Protocol document: