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Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

AstraZeneca logo

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)

239 participants in 2 patient groups

1
Active Comparator group
Description:
Temozolomide
Treatment:
Drug: Temozolomide
2
Experimental group
Description:
AZD6244
Treatment:
Drug: AZD6244

Trial contacts and locations

33

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Data sourced from clinicaltrials.gov

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