Hematologic Malignancies Clinical Trial
Official title:
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, dose escalation study of oral administration of MLN0128 in combination with paclitaxel, with/without trastuzumab, in participants 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 maximum tolerated dose (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 participants into 2 arms in
parallel:
- Arm A will consist of HER2- unknown cancer participants receiving MLN0128+paclitaxel
- Arm B will consist of HER2+ cancer participants receiving MLN0128+paclitaxel plus weekly
trastuzumab
;
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