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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.)
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00975806
First received: September 9, 2009
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975806

Locations
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
Investigators
Study Director: Abderrahim Fandi, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov 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
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lenalidomide
Sunitinib
 Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013