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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00936221
First received: July 8, 2009
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Melanoma
Drug: AZD2644
Drug: Dacarbazine
Drug: Placebo
Phase 2

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
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome 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. ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • To investigate the pharmacokinetics of AZD6244 [ Time Frame: At Day 1 and Day 22 ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: July 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AZD6244 in combination with dacarbazine
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
Other Name: DTIC
Placebo Comparator: 2
Placebo in combination with dacarbazine
Drug: Dacarbazine
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Other Name: DTIC
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936221

  Show 38 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Mark Middleton, Dr Churchil Hospital, Oxford, UK
Principal Investigator: Caroline Robert, Dr Institute Gustave Roussy, France
Study Director: Ian Smith, Dr AstraZeneca, Alderley Park, UK
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00936221     History of Changes
Other Study ID Numbers: D1532C00006
Study First Received: July 8, 2009
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
BRAF mutation positive
advanced melanoma
Advanced cutaneous melanoma
Unknown primary melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014