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Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00338130
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Melanoma Drug: AZD6244 Drug: Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Active Comparator: 1
Temozolomide
Drug: Temozolomide
oral

Experimental: 2
AZD6244
Drug: AZD6244
Oral liquid or Capsule
Other Name: ARRY-142886




Primary Outcome Measures :
  1. 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) ]
  2. Time to death [ Time Frame: From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest) ]
  3. Objective Response Rate [ Time Frame: RECIST data collected as per institutional standard practise ]
  4. Duration of response [ Time Frame: RECIST data collected as per institutional standard practise ]

Secondary Outcome Measures :
  1. Assessment of the safety and tolerability of AZD6244 [ Time Frame: Assessed at all visits ]
  2. Investigation of the pharmacokinetics of AZD6244 [ Time Frame: Day 1 & 8 (for patients on AZD6244) ]
  3. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338130


Locations
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United States, California
Research Site
Santa Monica, California, United States
United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Florida
Research Site
Miami Beach, Florida, United States
United States, Illinois
Research Site
Niles, Illinois, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Argentina
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Vicente Lopez, Argentina
Australia
Research Site
Heidelberg, Australia
Research Site
Nedlands, Australia
Research Site
Waratah, Australia
Austria
Research Site
St. Pölten, Austria
Research Site
Wien, Austria
Brazil
Research Site
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
Canada, Ontario
Research Site
Oshawa, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Denmark
Research Site
Odense, Denmark
France
Research Site
Boulogne Billancourt, France
Research Site
Nantes Cedex 1, France
Research Site
Villejuif Cedex, France
Switzerland
Research Site
Zürich, Switzerland
United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
London, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AZD6244 Medical Science Director, MD AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00338130    
Other Study ID Numbers: D1532C00003
EUDRACT No. 2006-001456-12
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by AstraZeneca:
Melanoma
Phase II
AZD6244
temozolomide
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents