Conditions: Melanoma Metastatic Melanoma Skin Cancer
Keywords: Temozolomide Skin cancer Melanoma Metastatic Melanoma ABT-888 MM
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 346
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy of ABT-888 in combination with temozolomide versus temozolomide alone in subjects with metastatic melanoma.

Detailed description:

Arms:
arm 1: Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. arm 2: ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. arm 3: ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.

Interventions: intervention 1: temozolomide intervention 2: ABT-888 intervention 3: Placebo
Intervention descriptions: intervention 1: temozolomide capsule administered orally once daily for 5 days every 28 days intervention 2: ABT-888 capsule administered orally twice daily for 7 days every 28 days intervention 3: Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days

Protocol document: