A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma
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Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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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.
Progression-Free Survival (PFS): Time to Event
Time Frame: Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.
Overall Survival (OS): Time to Event
Time Frame: Per protocol, survival follow-up information was to be obtained every 3 months for up to 18 months after the final visit for the subject. The maximum observed follow-up at the overall survival analysis time was 21.0 months.
12-Month Overall Survival (OS) Rate
Time Frame: Per protocol, survival was to be assessed every 4 weeks or as needed after participant is registered as off-study for up to 18 months. The maximum observed follow-up at the overall survival analysis time was 21.0 months.
6-month Progression-Free Survival Rate
Time Frame: Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.
Objective Response Rate
Time Frame: Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.
Time to Disease Progression
Time Frame: Every Cycle (28 Days), until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.
Disease Control Rate
Time Frame: Week 8
Time to Neurological/Brain Metastases Progression
Time Frame: Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.
Interventions:
- Drug: temozolomide
- Drug: temozolomide
- Drug: temozolomide
- Drug: ABT-888
- Drug: ABT-888
- Other: Placebo
Enrollment:
346
Additional Information
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