At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 55 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.
Study of the Effect of Esomeprazole or Rifampin on the Pharmacokinetics of Alisertib and Evaluation of the Effect of Alisertib on the QTc Interval in Patients With Advanced Solid Tumors or Lymphomas
In Brief
A Phase 1 clinical trial evaluating Alisertib, Esomeprazole, and 1 other intervention for Solid Tumors and Lymphoma. Completed, enrolled 55 participants across 7 sites.
Detailed Summary
The purpose of this study is to assess the drug-drug interaction (DDI) of either esomeprazole or rifampin on the single-dose PK of alisertib, and to complete an intensive QT study of single and multiple-dose alisertib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors, Lymphoma
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJun 2013
Primary CompletionAug 2014
Study CompletionSep 2016
TodayJul 2026
First PostedMay 1, 2013
Enrollment StartJun 25, 2013
Primary CompletionAug 4, 2014
Study CompletionSep 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.2 years ago
Interventions
Alisertibdrug
Alisertib tablets
Esomeprazoledrug
Esomeprazole capsules
Rifampindrug
Rifampin capsules