Status:
COMPLETED
Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients
Lead Sponsor:
AstraZeneca
Conditions:
Melanoma
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief 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 o...
Eligibility Criteria
Inclusion
- Histological or cytological confirmation of advanced (inoperable stage III and stage IV) cutaneous or unknown primary melanoma
- Tumor sample confirmed as BRAF mutation positive
Exclusion
- Diagnosis of uveal or mucosal melanoma
- Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK
- Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00936221
Start Date
July 1 2009
End Date
November 1 2014
Last Update
March 14 2016
Active Locations (38)
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1
Research Site
Aurora, Colorado, United States
2
Research Site
Boston, Massachusetts, United States
3
Research Site
Belo Horizonte, Brazil
4
Research Site
Ijuí, Brazil