Randomised study to compare the efficacy of AZD6244 vs TMZ
Study identifier:D1532C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients with Unresectable AJCC Stage 3 or 4 Malignant Melanoma
Medical condition
Melanoma
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD6244, Temozolomide
Sex
All
Actual Enrollment
239
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Jul 2006
Primary Completion Date: 01 Sept 2007
Study Completion Date: 01 Jul 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Temozolomide | Drug: Temozolomide oral |
| Experimental: 2 AZD6244 | Drug: AZD6244 Oral liquid or Capsule Other Name: ARRY-142886 |
Contacts
Investigators
Principal Investigator
AZD6244 Medical Science Director
AstraZeneca
