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NCT00055562 Clinical Trial

Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma

Melanoma Clinical Trial

Official title:
Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2 or IFN Based Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00055562
Other study ID # CDC-5013-MEL-001
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 5, 2003
Last updated June 23, 2005
Start date January 2003
Est. completion date December 2004

Study information
Verified date May 2004
Source Celgene
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects will be treated in repeating 4 week cycles.

Other known NCT identifiers
  • NCT00060281

Recruitment information / eligibility
Status Completed
Enrollment 274
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - Understand and voluntarily sign an informed consent form.

- Able to adhere to the study visit schedule and other protocol requirements.

- Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy.

- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug.

- Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CC 5013

Locations
Country Name City State
Canada Tom Baker Cancer Center Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Qell Health Sciences Center Halifax Nova Scotia
Canada L'Hotel Dieu de Quebec Quebec
Canada Princess Margaret Hospital Toronto Ontario
Canada Cancer Care Manitoba Winnipeg Manitoba
United States University of Colorado Aurora Colorado
United States Beth Israel Deaconess Medical Ctr Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States The Linder Clinical Trial Center Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Ellis Fischel Cancer Center Columbia Missouri
United States Spectrum Health Grand Rapids Michigan
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States MD Anderson Cancer Center Houston Texas
United States Lakeland Regional Cancer Center Lakeland Florida
United States UCLA Los Angeles California
United States University of Southern California Norris Cancer Center Los Angeles California
United States Mount Sinai Comprehensive Cancer Center Miami Beach Florida
United States Sarah Cannon Cancer Center Nashville Tennessee
United States Biomedical Research Alliance of New York New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Lutheran General Park Ridge Illinois
United States UPMC Cancer Pavillion Pittsburgh Pennsylvania
United States St. Francis Memorial Hospital San Francisco California
United States Outpatient Clinic Santa Monica California
United States Melanoma Center of St Louis St. Louis Missouri
United States Washington University School of Medicine St. Louis Missouri
United States University of Arizona Cancer Center Tucson Arizona
United States Carle Clinic Urbana Illinois
United States The Harold Lever Regional Cancer Center Waterbury Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Celgene Corporation

Countries where clinical trial is conducted

United States,  Canada, 

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