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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase 1: Maximum Tolerated Dose (MTD)

Outcome Time Frame:

Within 21 days of treatment induction

Safety Issue:

No

Principal Investigator

Abderrahim Fandi, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-RCC-001

NCT ID:

NCT00975806

Start Date:

September 2009

Completion Date:

October 2011

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Tennessee OncologyNashville, Tennessee  37203
Cleveland Clinic Main CampusCleveland, Ohio  44195