Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients
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...
Brief Summary
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”
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
- Study Type: 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
- Study Primary Completion Date: June 2012
Intervention(s) in this Clinical Trial
- Drug: AZD2644
- oral capsules, 75mg twice daily
- Drug: Dacarbazine
- 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- AZD6244 in combination with dacarbazine
- Placebo Comparator: 2
- Placebo in combination with dacarbazine
Outcome Measures for this Clinical Trial
Primary Measures
- 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.
Safety Issue?: No
- 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 Measures
- 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
Safety Issue?: No
- 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)
Safety Issue?: Yes
- 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
Safety Issue?: No
- Time Frame: At Day 1 and Day 22
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Mark Middleton, Dr Principal Investigator Churchil Hospital, Oxford, UK
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00936221
Study ID Number: D1532C00006
ClinicalTrials.gov Identifier: NCT00936221
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00936221
