Phase 2 Completed N=91 Randomized Quadruple-blind Treatment

Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

Melanoma

Source: ClinicalTrials.gov NCT00936221 ↗

Enrolled (actual)

Serious AEs

33.7%

Results posted

Dec 2015

Primary outcomePrimary: Overall Survival — 424; 321 Days — p=0.3873

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

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.