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Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

NCT00936221 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2016-03-14

Study results available
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Summary

To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Conditions

Interventions

DRUG

AZD6244

oral capsules, 75mg twice daily

DRUG

Dacarbazine

1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Mark Middleton, Dr · Churchil Hospital, Oxford, UK

  • Caroline Robert, Dr · Institute Gustave Roussy, France

  • Ian Smith, Dr · AstraZeneca, Alderley Park, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-11-30
Completion
2014-11-30

Countries

  • United States
  • Brazil
  • Czechia
  • France
  • Germany
  • Hungary
  • Netherlands
  • Norway
  • 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 NCT00936221 on ClinicalTrials.gov