NCT01351350

Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Advanced Solid Malignancies
• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	MLN0128	MLN0128 capsules
DRUG	paclitaxel	paclitaxel intravenous infusion
DRUG	trastuzumab	trastuzumab intravenous infusion

Timeline

• Start date: 2011-02-28
• Primary completion: 2017-09-15
• Completion: 2017-09-15
• First posted: 2011-05-10
• Last updated: 2019-08-08
• Results posted: 2019-08-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study