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

NCT00257205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2012-07-02

No results posted yet for this study

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)

Conditions

Interventions

DRUG

dacarbazine

decarbazine 1000 mg/m2 IV Q 21 days x 12

DRUG

CP-675,206

CP-675,206 15 mg/kg IV Q 90 days x 4

DRUG

temozolomide

temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00257205 on ClinicalTrials.gov