Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(MTD determined sub-optimal as efficacious treatment for renal cell carcinoma.)
Information provided by (Responsible Party):
Celgene Corporation Identifier:
First received: September 9, 2009
Last updated: April 9, 2012
Last verified: April 2012

The purpose of this study is 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.

Condition Intervention Phase
Renal Cell Carcinoma
Drug: Lenalidomide (CC-5013) in combination with sunitinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Phase 1: Maximum Tolerated Dose (MTD) [ Time Frame: Within 21 days of treatment induction ] [ Designated as safety issue: No ]
  • Phase 2: Tumor Response Rate (RECIST 1.1) [ Time Frame: After at least 3 cycles of treatment have been completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (type, frequency, and severity of adverse events (AEs) and relationship of AEs to study drug) [ Time Frame: Once informed consent is signed until 28 days after last dose ] [ Designated as safety issue: Yes ]
  • Tumor Response Rate according to RECIST 1.1 (Primary endpoint in Phase 2 and secondary endpoint in Phase 1) [ Time Frame: After at least 3 cycles of treatment have been completed ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: From start of therapy to progression using RECIST 1.1, death, or discontinuation ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Length of time from response per RECISIT 1.1 until progression, death, or discontinuation ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Length of time from start of therapy until death, lost to follow up, or 5 years after treatment discontinuation ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Single Arm: Lenalidomide (CC-5013) administered in combination with sunitinib
Drug: Lenalidomide (CC-5013) in combination with sunitinib
Lenalidomide MTD mg daily for Days 1- 21 in combination with sunitinib 37.5 mg daily for Days 1-21 of a 21 day cycle until disease progression


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Metastatic Renal Cell Carcinoma.
  2. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00975806

United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Celgene Corporation
Study Director: Abderrahim Fandi, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation Identifier: NCT00975806     History of Changes
Other Study ID Numbers: CC-5013-RCC-001
Study First Received: September 9, 2009
Last Updated: April 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 24, 2014