NCT02699749

A Study to Evaluate TAK-931 in Participants With Advanced Nonhematologic Tumors

An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-931, a Cell Division Cycle 7 (CDC7) Inhibitor, in Adult Patients With Advanced Nonhematologic Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and maximum tolerated dose (MTD) of TAK-931 in participants with advanced nonhematologic tumors.

Detailed description

The drug being under investigation in this study is called TAK-931. The effect of TAK-931 is being evaluated in up to 100 participants who have nonhematologic (solid) neoplasms. This study will look at the safety, tolerability, and PK to determine the maximum tolerated dose (MTD) of TAK-931. This multi-center trial will be conducted in Japan. The overall study duration is approximately 42 months for total of dose escalation cohorts and the safety expansion cohort. Participants will make multiple visits to the clinic with final visit approximately 30-40 days after last dose of study drug for a follow-up assessment.

Conditions

• Nonhematologic Neoplasms, Advanced

Interventions

Type	Name	Description
DRUG	TAK-931	TAK-931 oral capsules.

Timeline

• Start date: 2016-03-24
• Primary completion: 2019-12-21
• Completion: 2019-12-21
• First posted: 2016-03-04
• Last updated: 2021-02-21
• Results posted: 2021-02-21

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study