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

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Cell Carcinoma

Intervention: Lenalidomide (CC-5013) in combination with sunitinib (Drug); Lenalidomide (Drug); Sunitinib (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Debora Barton, MD, Study Director, Affiliation: Celgene Corporation


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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Phase 1: Maximum Tolerated Dose (MTD)

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

Secondary outcome:

Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib

Phase 1 : Tumor Response Rate According to RECIST 1.1

Progression Free Survival (PFS)

Duration of Response

Overall Survival (OS)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109, United States

Cleveland Clinic Main Campus, Cleveland, Ohio 44195, United States

Tennessee Oncology, Nashville, Tennessee 37203, United States

Additional Information

Starting date: September 2009
Last updated: February 3, 2015

Page last updated: August 23, 2015

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