NCT02327169

A Study MLN2480 in Combination With MLN0128 or Alisertib, or Paclitaxel, or Cetuximab, or Irinotecan in Adult Participants With Advanced Nonhematologic Malignancies

A Multiarm, Open-label, Phase 1b Study of MLN2480 (an Oral A-, B-, and CRAF Inhibitor) in Combination With MLN0128 (an Oral mTORC 1/2 Inhibitor), or Alisertib (an Oral Aurora A Kinase Inhibitor), or Paclitaxel, or Cetuximab, or Irinotecan, in Adult Patients With Advanced Nonhematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine the safety profile and the maximum tolerated doses (MTDs)/ potential recommended phase 2 doses (RP2Ds) of the combination treatments of MLN2480 + MLN0128, MLN2480 + alisertib, MLN2480 + paclitaxel, MLN2480 + cetuximab, and MLN2480 + irinotecan in participants with advanced nonhematologic malignancies.

Detailed description

The drug being tested in this study is called MLN2480 (TAK-580). MLN2480 was tested to evaluate side effects and determine the maximum tolerated dose (MTD) and recommended dose for future studies when administered in combination with five other medications. This study was to assess the safety of MLN2480 as well as how it is processed by the body in participants with solid nonhematologic malignancies who have failed standard therapies. The study was to be conducted in two phases, the dose escalation phase and the dose expansion phase. A total of 71 participants were enrolled in the escalation phase. Participants in this phase were assigned to one of the five treatment groups: * MLN2480 + MLN0128 * MLN2480 + Alisertib * MLN2480 + Paclitaxel * MLN2480 + Cetuximab * MLN2480 + Irinotecan Once the MTD for each combination treatment arm was established in the escalation phase, one or more of the combination treatments will be selected for the expansion phase. A total of 10 participants were enrolled in the expansion phase. This multi-centre trial was be conducted worldwide. The overall time to participate in this study is approximately 14 months. Participants made multiple visits to the clinic including an end of study visit 30 days after last dose of study drug for a follow-up assessment.

Conditions

• Advanced Nonhematologic Malignancies

Interventions

Type	Name	Description
DRUG	MLN2480	MLN2480 tablets.
DRUG	MLN0128	MLN0128 capsules.
DRUG	Alisertib	Alisertib tablets.
DRUG	Paclitaxel	Paclitaxel IV infusion.
DRUG	Cetuximab	Cetuximab IV infusion.
DRUG	Irinotecan	Irinotecan IV infusion.

Timeline

• Start date: 2015-01-14
• Primary completion: 2018-07-02
• Completion: 2018-07-02
• First posted: 2014-12-30
• Last updated: 2020-02-25
• Results posted: 2020-02-25

Locations

14 sites across 4 countries: United States, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study