Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Melanoma

Treatments: Drug: Temozolomide; Drug: AZD6244

Study type: Interventional

Funder types: Industry

Identifiers

NCT00338130

D1532C00003

EUDRACT No. 2006-001456-12

Details and patient eligibility

About

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

Enrollment: 239 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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239 participants in 2 patient groups

1

Active Comparator group

Description:

Temozolomide

Treatment:

Drug: Temozolomide

2

Experimental group

Description:

AZD6244

Treatment:

Drug: AZD6244