Phase 2
N=91
Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00936221 ↗Enrolled (actual)
91
Serious AEs
33.7%
Results posted
Dec 2015
Primary outcome: Primary: Overall Survival — 424; 321 Days — p=0.3873
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD6244 (Drug); Dacarbazine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
424; 321 | 0.3873 |
| SECONDARY Progression Free Survival |
169; 92 | — |
| SECONDARY Objective Response Rate |
18; 12; 1; 1; 17; 11 | — |
| SECONDARY Change in Target Lesion Tumour Size at Week 12 |
-8.85; 0.22 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00936221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.