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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Melanoma

Treatments: Drug: AZD6244; Drug: Dacarbazine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00936221

D1532C00006

Details and patient eligibility

About

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

Enrollment: 385 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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385 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

AZD6244 in combination with dacarbazine

Treatment:

Drug: Dacarbazine

Drug: AZD6244

2

Placebo Comparator group

Description:

Placebo in combination with dacarbazine

Treatment:

Drug: Dacarbazine

Drug: Placebo