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

Celgene

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Drug: Sunitinib; Drug: Lenalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975806

CC-5013-RCC-001

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Cohort A

Experimental group

Description:

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

Treatment:

Drug: Lenalidomide

Drug: Sunitinib

Cohorts F and G

Experimental group

Description:

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

Treatment:

Drug: Lenalidomide

Drug: Sunitinib