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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Overall survival calculated as the interval from date of randomisation to date of patient death (any cause). Patients who have not died at final analysis, or who withdraw consent, will be censored at last date they were known to be alive.

Safety Issue:

No

Principal Investigator

Mark Middleton, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Churchil Hospital, Oxford, UK

Authority:

United States: Food and Drug Administration

Study ID:

D1532C00006

NCT ID:

NCT00936221

Start Date:

July 2009

Completion Date:

June 2013

Related Keywords:

  • Melanoma
  • BRAF mutation positive
  • advanced melanoma
  • Advanced cutaneous melanoma
  • Unknown primary melanoma
  • Melanoma

Name

Location

Research SiteBoulder, Colorado  
Research SiteBeverly, Massachusetts  
Research SiteAbilene, Texas