Status:
COMPLETED
CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy
Lead Sponsor:
AstraZeneca
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 trea...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
655 Patients enrolled
Trial Details
Trial ID
NCT00257205
Start Date
March 1 2006
End Date
August 1 2010
Last Update
July 2 2012
Active Locations (143)
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1
Research Site
Huntsville, Alabama, United States, 35805
2
Research Site
Mobile, Alabama, United States, 36607
3
Research Site
Scottsdale, Arizona, United States, 85260
4
Research Site
Little Rock, Arkansas, United States, 72205