Overview

A Safety, Tolerability, and Pharmacokinetics Study of MLN0128 as a Single Agent and in Combination With Paclitaxel in Adults With Advanced Nonhematologic Malignancies

Status:
Completed

Trial end date:
2018-05-31

Target enrollment:

Participant gender:

Summary

The purposes of this study are to evaluate the safety and tolerability of sapanisertib (MLN0128) milled active pharmaceutical ingredient (API) capsules administered both as a single agent and in combination with paclitaxel, to characterize the effect of a high-fat meal on the pharmacokinetics (PK) of sapanisertib milled API capsules, and to characterize the PK of sapanisertib milled API capsules when administered on an empty stomach approximately 24 hours after paclitaxel infusion.

Phase:

Phase 1

Details

Lead Sponsor:

Millennium Pharmaceuticals, Inc.

Treatments:

Albumin-Bound Paclitaxel
Paclitaxel