At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 178 enrolled
Drug / intervention
Alisertib +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 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC).
In Brief
A Phase 2 clinical trial evaluating Alisertib, Placebo, and 1 other intervention for Small Cell Lung Cancer. Completed, enrolled 178 participants across 61 sites in 10 countries.
Detailed Summary
This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study designed to is to determine if the combination treatment can improve progression free survival (defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first) when compared with placebo + paclitaxel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer
CountriesBelgium, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartMay 2014
Primary CompletionJan 2016
Study CompletionJul 2017
TodayJul 2026
First PostedJan 16, 2014
Enrollment StartMay 12, 2014
Primary CompletionJan 3, 2016
Study CompletionJul 10, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.5 years ago
Interventions
Alisertibdrug
Alisertib tablets
Placebodrug
Placebo matching tablets
Paclitaxeldrug
Paclitaxel intravenous injection