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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-01

Study Completion Date

2011-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A

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

Group Type EXPERIMENTAL

Lenalidomide

Intervention Type DRUG

Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination

Sunitinib

Intervention Type DRUG

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

Cohorts F and G

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

Group Type EXPERIMENTAL

Lenalidomide

Intervention Type DRUG

Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination

Sunitinib

Intervention Type DRUG

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

Interventions

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Lenalidomide

Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination

Intervention Type DRUG

Sunitinib

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

Intervention Type DRUG

Other Intervention Names

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CC-5013 Revlimid Sutent

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No