NCT02719691

Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to evaluate the combination of Alisertib and MLN0128 in patients with advanced solid tumors refractory to standard treatment followed by an expansion cohort of patients with metastatic TNBC with exploratory correlative studies.

Conditions

• Metastatic Breast Cancer
• Solid Tumors

Interventions

Type	Name	Description
DRUG	Alisertib	Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
DRUG	MLN0128	Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

Timeline

• Start date: 2016-05-13
• Primary completion: 2020-03-18
• Completion: 2020-03-18
• First posted: 2016-03-25
• Last updated: 2022-07-25
• Results posted: 2022-01-19

Locations

1 site across 1 country: United States