NCT02675491

Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors

Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.

Detailed description

This study is single arm study with DS-6051b in approximately 9 subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene. Safety and tolerability, pharmacokinetics (PK), maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) and preliminary efficacy of DS-6051b will be evaluated.

Conditions

• Advanced Solid Malignant Tumors

Interventions

Type	Name	Description
DRUG	DS-6051b	Drug: DS-6051b 400 mg or 800 mg daily

Timeline

• Start date: 2016-02-10
• Primary completion: 2021-12-27
• Completion: 2021-12-28
• First posted: 2016-02-05
• Last updated: 2024-12-16

Locations

3 sites across 1 country: Japan