At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 346 enrolled
Drug / intervention
temozolomide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy of ABT-888 in Combination With Temozolomide Versus Temozolomide Alone in Subjects With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating temozolomide, ABT-888, and 1 other intervention for Melanoma and 2 related conditions. Completed, enrolled 346 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma, Metastatic Melanoma, Skin Cancer
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartFeb 2009
Primary CompletionJan 2016
TodayJul 2026
First PostedDec 9, 2008
Enrollment StartFeb 1, 2009
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 17.6 years ago
Interventions
temozolomidedrug
temozolomide capsule administered orally once daily for 5 days every 28 days
ABT-888drug
ABT-888 capsule administered orally twice daily for 7 days every 28 days
Placeboother
Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days