At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 47 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 Ib Study of the Combination of MLN0128 (Dual TORC1/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients With Advanced Solid Tumors With an Expansion Cohort in Metastatic Triple-negative Breast Cancer (TNBC)
In Brief
A Phase 1 clinical trial evaluating Alisertib and MLN0128 for Metastatic Breast Cancer and Solid Tumors. Completed, enrolled 47 participants across 1 site.
Detailed Summary
This is a phase Ib study designed to evaluate the safety and toxicity of the combination of Alisertib and MLN0128 in patients with advanced solid tumors with an expansion cohort in patients with previously treated metastatic TNBC.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer, Solid Tumors
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartMay 2016
Primary CompletionMar 2020
TodayJul 2026
First PostedMar 25, 2016
Enrollment StartMay 13, 2016
Primary CompletionMar 18, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.3 years ago
Interventions
Alisertibdrug
Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128drug
Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.