Comparison of AZD6244 in combination with dacarbazine versus (vs) dacarbazine alone in BRAF mutation positive melanoma patients

Study identifier:D1532C00006

ClinicalTrials.gov identifier:NCT00936221

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase II, Double-blind, Randomised study to assess the efficacy of AZD6244 in combination with dacarbazine compared with dacarbazine alone in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Medical condition

Melanoma

Phase

Phase 2

Healthy volunteers

No

Study drug

AZD6244, Dacarbazine, Placebo

Sex

All

Actual Enrollment

385

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 01 Jul 2009
Primary Completion Date: 01 Nov 2011
Study Completion Date: 01 Nov 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria