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

February 11, 2016 updated by: AstraZeneca

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte, Brazil
        • Research Site
      • Ijuí, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Novy Jicin, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
  • France
      • Lille Cedex, France
        • Research Site
      • Marseille, France
        • Research Site
      • Villejuif Cedex, France
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Tübingen, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Györ, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
  • Norway
      • Oslo, Norway
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Houston, Spain
        • Research Site
      • Málaga, Spain
        • Research Site
      • Palma de Mallorca, Spain
        • Research Site
  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Malmö, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
  • Switzerland
      • Zürich, Switzerland
        • Research Site
  • United Kingdom
      • Cambridge, United Kingdom
        • Research Site
      • Chelmsford, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Newcastle upon Tyne, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site
      • Sutton, United Kingdom
        • Research Site
  • United States
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
AZD6244 in combination with dacarbazine
Drug: AZD6244
oral capsules, 75mg twice daily
Other Names:
  • selumetinib
Drug: Dacarbazine
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Other Names:
  • DTIC
Placebo Comparator: 2
Placebo in combination with dacarbazine
Drug: Placebo
Placebo
Drug: Dacarbazine
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Other Names:
  • DTIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later
Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.
From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
Objective Response Rate
Time Frame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR
From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
Change in Target Lesion Tumour Size at Week 12
Time Frame: randomization to week 12
randomization to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1532C00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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