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.
A Phase 1 Dose Escalation and Pharmacokinetic Study of Alisertib (MLN8237), an Aurora A Kinase Inhibitor, in Adult East Asian Patients With Advanced Solid Tumors or Lymphomas
In Brief
A Phase 1 clinical trial evaluating Alisertib for Advanced Solid Tumors and Lymphomas. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The purpose of this study was to determine the safety profile, maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to characterize the pharmacokinetic (PK) profile of alisertib twice daily (BID) dosing for 7 days in East Asian participants with advanced solid tumors or lymphomas. The secondary objective was to describe any antitumor activity that may have been observed with alisertib treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors, Lymphomas
CountriesSingapore
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 2012
Enrollment StartFeb 2012
Primary CompletionOct 2013
TodayJul 2026
First PostedJan 19, 2012
Enrollment StartFeb 6, 2012
Primary CompletionOct 8, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.5 years ago
Interventions
Alisertibdrug
Alisertib enteric-coated tablets