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COMPLETEDPHASE3

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

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

NCT00257205•AstraZeneca

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (143)

Research Site

Huntsville, Alabama, United States

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

Key Dates

Start Date

March 1, 2006

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2010

Last Updated

July 2, 2012

Enrollment

655

ACTUAL participants

Conditions

Melanoma

Interventions

dacarbazine

DRUG

CP-675,206

DRUG

temozolomide

DRUG

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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