Overview

This trial is active, not recruiting.

Condition melanoma
Treatments azd2644, dacarbazine, placebo
Phase phase 2
Sponsor AstraZeneca
Start date July 2009
End date November 2011
Trial size 385 participants
Trial identifier NCT00936221, D1532C00006

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
AZD6244 in combination with dacarbazine
azd2644
oral capsules, 75mg twice daily
dacarbazine DTIC
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
(Placebo Comparator)
Placebo in combination with dacarbazine
dacarbazine DTIC
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
placebo
Placebo

Primary Outcomes

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
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.

Secondary Outcomes

Measure
To further assess the efficacy in terms of-Alive and Progression Free at 6 months (APF6)- Progression Free Survival (PFS)- Objective Response Rate (ORR)- Duration of Response (DoR)- Change in tumour size at 12 weeks
time frame: APF6, PFS, ORR, DoR, and change in tumour size at 12 weeks will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 12 and every 12 weeks thereafter relative to randomisation
To assess the safety and tolerability profile of AZD6244 in combination with dacarbazine
time frame: At every visit (ie weekly for the first 6 weeks and then every 3 weeks)
To investigate the pharmacokinetics of AZD6244
time frame: At Day 1 and Day 22

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Mark Middleton, Dr
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by AstraZeneca.