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Sponsored by: |
AstraZeneca |
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00338130 |
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma
Condition | Intervention | Phase |
Melanoma |
Drug: AZD6244 Drug: Temozolomide |
Phase II |
MedlinePlus related topics: | Melanoma |
ChemIDplus related topics: | Temozolomide ARRY 142886 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 182 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
1: Active Comparator
Temozolomide
|
Drug: Temozolomide
oral
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2: Experimental
AZD6244
|
Drug: AZD6244
oral liquid
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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Show 40 Study Locations |
AstraZeneca |
Study Director: | AZD6244 Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D1532C00003, EUDRACT No. 2006-001456-12 |
First Received: | June 15, 2006 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00338130 |
Health Authority: | United States: Food and Drug Administration |
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