NCT02045095

A Dose Escalation Study of MLN7243 (TAK-243) in Adult Participants With Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety and Tolerability of MLN7243, an Inhibitor of Ubiquitin-Activating Enzyme (UAE), in Adult Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety and tolerability (establish maximum tolerated dose \[MTD\], inform the recommended phase 2 dose \[RP2D\], and identify the dose-limiting toxicities \[DLTs\]) of MLN7243.

Detailed description

This is a single arm Phase I study with multiple dosing cohorts as noted below: * Schedule A: MLN7243 1 mg * Schedule A: MLN7243 2 mg * Schedule A: MLN7243 4 mg * Schedule A: MLN7243 8 mg * Schedule A: MLN7243 12 mg * Schedule A: MLN7243 18 mg * Schedule A: MLN7243 Homozygous Mutant 4 mg

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	MLN7243	Dose escalation stage Schedule A: Intravenous infusion on Days 1, 4, 8, 11 for a 21-day treatment cycle. Schedule B: Intravenous infusion on Days 1, 8, 15 for a 28-day treatment cycle. Dose expansion stage: MLN7243 will be administered following schedule A (twice-weekly, 21-day dosing) and/or B (once-weekly, 28-day dosing).

Timeline

• Start date: 2014-01-31
• Primary completion: 2016-11-09
• Completion: 2016-11-09
• First posted: 2014-01-24
• Last updated: 2019-03-14
• Results posted: 2019-03-14

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study