CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 3 enrolled
Drug / intervention
[^14C]-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.

Search/NCT01714947
NCT01714947Phase 1Completed
CompareCT.gov

Mass Balance, Pharmacokinetics, and Metabolism of [^14C]-Alisertib in Patients With Advanced Solid Tumors or Lymphomas

Millennium Pharmaceuticals, Inc.·interventional·Posted Oct 26, 2012·Updated Oct 31, 2018

In Brief

A Phase 1 clinical trial evaluating [^14C]-alisertib and alisertib for Advanced Solid Tumors and Lymphoma. Completed, enrolled 3 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity \[TRA\] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors, Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 26, 2012
Enrollment StartJan 24, 2013
Primary CompletionApr 4, 2013
Study CompletionJun 14, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.7 years ago

Interventions

[^14C]-alisertibdrug

\[\^14C\]-alisertib oral solution

alisertibdrug

Alisertib enteric coated tablets