Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

August 12, 2014 updated by: AstraZeneca

A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma

The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

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

  • Argentina
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Vicente Lopez, Argentina
        • Research Site
  • Australia
      • Heidelberg, Australia
        • Research Site
      • Nedlands, Australia
        • Research Site
      • Waratah, Australia
        • Research Site
  • Austria
      • St. Pölten, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Brazil
      • Belo Horizonte, Brazil
        • Research Site
      • Curitiba, Brazil
        • Research Site
      • Goiânia, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Salvador, Brazil
        • Research Site
      • São Paulo, Brazil
        • Research Site
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • Denmark
      • Odense, Denmark
        • Research Site
  • France
      • Boulogne Billancourt, France
        • Research Site
      • Nantes Cedex 1, France
        • Research Site
      • Villejuif Cedex, France
        • Research Site
  • Switzerland
      • Zürich, Switzerland
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site
  • United States
    • California
      • Santa Monica, California, United States
        • Research Site
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
    • Florida
      • Miami Beach, Florida, United States
        • Research Site
    • Illinois
      • Niles, Illinois, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • New York
      • Buffalo, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Nashville, Tennessee, 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with late stage malignant melanoma
  • Aged 18 or over
  • Female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal

Exclusion Criteria:

  • Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable)
  • Participation in any other trial with an investigational product within the previous 30 days

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Temozolomide
Drug: Temozolomide
oral
Experimental: 2
AZD6244
Drug: AZD6244
Oral liquid or Capsule
Other Names:
  • ARRY-142886

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS)
Time Frame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Time to death
Time Frame: From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
Objective Response Rate
Time Frame: RECIST data collected as per institutional standard practise
RECIST data collected as per institutional standard practise
Duration of response
Time Frame: RECIST data collected as per institutional standard practise
RECIST data collected as per institutional standard practise

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the safety and tolerability of AZD6244
Time Frame: Assessed at all visits
Assessed at all visits
Investigation of the pharmacokinetics of AZD6244
Time Frame: Day 1 & 8 (for patients on AZD6244)
Day 1 & 8 (for patients on AZD6244)
Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive
Time Frame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: AZD6244 Medical Science Director, MD, AstraZeneca

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.

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, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 15, 2006

First Submitted That Met QC Criteria

June 16, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1532C00003
  • EUDRACT No. 2006-001456-12

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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