A Phase I, Open Label, Dose Escalation Study of Oral Administration of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies
This is a Phase I, open-label study consisting of a dose escalation phase in advanced solid
malignancies to determine the MTD of oral administration of MLN0128 in 1 or more dosing
schedules, combined with paclitaxel on Days 1, 8 and 15 of each cycle, followed by an
expansion phase for further safety and preliminary efficacy. Once the MTD is determined
for each of the dosing schedules evaluated, a dose and schedule will be selected for the
expansion phase, which may enroll subjects into 2 arms in parallel:
- Arm A will consist of HER2-/unknown cancer subjects receiving MLN0128+paclitaxel
- Arm B will consist of HER2+ cancer subjects receiving MLN0128+paclitaxel plus weekly
trastuzumab
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) and number of Dose-Limiting Toxicities (DLTs)
To determine the MTD and DLT of MLN0128 in combination with paclitaxel
Cycle 1: Days 1-28
Yes
Medical Monitor
Study Director
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
INK128-003
NCT01351350
March 2011
August 2014
Name | Location |
---|---|
Miami, Florida 33176 | |
Nashville, Tennessee 37203-1632 | |
Tulsa, Oklahoma |