CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

Completed · Phase 3

Conditions studied: Melanoma

In brief

This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

Key facts

Study ID

NCT00257205

Run by

AstraZeneca

People needed

655

Starts

2006-03-01

Expected to finish

2010-08-01

Last updated by the study team

2012-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
• Serum lactic acid dehydrogenase (LDH) <= 2 x ULN
• ECOG performance status of 0 or 1

You may not qualify if…

• Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
• History of brain metastases

Where it is running

• Research Site — Mobile, Alabama, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Bakersfield, California, United States
• Research Site — Corona, California, United States
• Research Site — Fullerton, California, United States
• Research Site — Glendora, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Alamitos, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Oxnard, California, United States
• Research Site — Pasadena, California, United States
• Research Site — Pomona, California, United States
• Research Site — Rancho Cucamonga, California, United States
• Research Site — Santa Barbara, California, United States
• Research Site — Santa Maria, California, United States
• Research Site — West Covina, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Lake Worth, Florida, United States
• Research Site — Zion, Illinois, United States
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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