At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Alisertibdrug
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.
Pharmacokinetics of Oral Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Alisertib for Advanced Solid Tumors and Relapsed/Refractory Lymphoma. Completed, enrolled 36 participants across 7 sites.
Detailed Summary
The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment on the single-dose pharmacokinetics of alisertib in adult participants with cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartAug 2014
Primary CompletionApr 2016
Study CompletionJul 2016
TodayJul 2026
First PostedAug 12, 2014
Enrollment StartAug 21, 2014
Primary CompletionApr 5, 2016
Study CompletionJul 18, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.9 years ago
Interventions
Alisertibdrug
Alisertib will be supplied as enteric coated tablets.