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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00055562
• Date of registration: 05/03/2003
• Primary sponsor: Celgene Corporation
• Public title: Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma
• Scientific 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
• Date of first enrolment: January 2003
• Target sample size: 274
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00055562
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Melanoma

Neoplasm Metastasis

Intervention(s)

Drug: CC 5013

Secondary ID(s)

CDC-5013-MEL-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors