CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
Sapanisertib +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/NCT02412722
NCT02412722Phase 1Completed
CompareCT.gov

A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLN0128 (an Oral mTORC 1/2 Inhibitor) as a Single Agent and in Combination With Paclitaxel in Adult Patients With Advanced Nonhematologic Malignancies

Millennium Pharmaceuticals, Inc.·interventional·Posted Apr 9, 2015·Updated Feb 28, 2020

In Brief

A Phase 1 clinical trial evaluating Sapanisertib and Paclitaxel for Non-hematologic Malignancy. Completed, enrolled 61 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-hematologic Malignancy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 9, 2015
Enrollment StartMar 26, 2015
Primary CompletionMay 31, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.2 years ago

Interventions

Sapanisertibdrug

Sapanisertib capsules

Paclitaxeldrug

Paclitaxel injection