Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2013-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Temozolomide

Group Type ACTIVE_COMPARATOR

Temozolomide

Intervention Type DRUG

oral

2

AZD6244

Group Type EXPERIMENTAL

AZD6244

Intervention Type DRUG

Oral liquid or Capsule

Interventions

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AZD6244

Oral liquid or Capsule

Intervention Type DRUG

Temozolomide

oral

Intervention Type DRUG

Other Intervention Names

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ARRY-142886

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No