At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 191 enrolled
Drug / intervention
Alisertib +1 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.
Randomized Phase 2 Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel or Weekly Paclitaxel Alone in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Preceded by a Phase 1 Portion in Patients With Ovarian or Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Alisertib and Paclitaxel for Ovarian Carcinoma and 3 related conditions. Completed, enrolled 191 participants across 4 sites.
Detailed Summary
This is an open-label, multicenter study with a nonrandomized Phase 1 portion and an open-label, randomized, Phase 2 portion evaluating MLN8237 in combination with weekly paclitaxel in adult female participants with advanced breast cancer (Phase 1 portion only) and recurrent ovarian cancer (both Phase 1 and Phase 2 portions).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartApr 2010
Primary CompletionAug 2014
Study CompletionJul 2017
TodayJul 2026
First PostedMar 24, 2010
Enrollment StartApr 16, 2010
Primary CompletionAug 12, 2014
Study CompletionJul 19, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.3 years ago
Interventions
Alisertibdrug
Alisertib tablets
Paclitaxeldrug
Paclitaxel intravenous infusion