A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma

AstraZeneca1 site in 1 country655 target enrollmentMarch 2006

ConditionsMelanoma

Interventionsdacarbazine temozolomide CP-675,206

Drugsdacarbazine CP-675,206 temozolomide

Overview

Phase: Phase 3
Intervention: dacarbazine
Conditions: Melanoma
Sponsor: AstraZeneca
Enrollment: 655
Locations: 1
Primary Endpoint: overall survival
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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)

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

August 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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