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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00055562
First received: March 5, 2003
Last updated: June 23, 2005
Last verified: May 2004
  Purpose

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.


Condition Intervention Phase
Melanoma
Neoplasm Metastasis
Drug: CC 5013
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Estimated Enrollment: 274
Study Start Date: January 2003
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  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 ClinicalTrials.gov identifier: NCT00055562

  Show 31 Study Locations
Sponsors and Collaborators
Celgene Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00055562     History of Changes
Obsolete Identifiers: NCT00060281
Other Study ID Numbers: CDC-5013-MEL-001
Study First Received: March 5, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Metastatic Melanoma
Metastatic Malignant Melanoma
Revimid
CC5013

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplastic Processes
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Pathologic Processes
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014