At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 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.
A Phase 1 Study to Evaluate the Effect of Itraconazole, a Strong CYP3A Inhibitor, on the Pharmacokinetics of Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
In Brief
A Phase 1 clinical trial evaluating Alisertib and Itraconazole for Advanced Solid Tumors and Relapsed/Refractory Lymphoma. Completed, enrolled 24 participants across 4 sites.
Detailed Summary
This study will assess the effect of multi-dose administration of itraconazole on the single-dose pharmacokinetics (PK) of alisertib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartOct 2014
Primary CompletionMar 2015
Study CompletionOct 2016
TodayJul 2026
First PostedOct 8, 2014
Enrollment StartOct 22, 2014
Primary CompletionMar 27, 2015
Study CompletionOct 21, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.7 years ago
Interventions
Alisertibdrug
Alisertib tablets
Itraconazoledrug
Itraconazole oral solution