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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02675491
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact
Status Completed
Phase Phase 1
Start date February 2016
Completion date December 28, 2021

See also
  Status Clinical Trial Phase
Terminated NCT02192567 - Open Label Study of DS-5573a Phase 1
Completed NCT02690337 - Study of DS-1123a in Advanced Solid Tumours Phase 1
Completed NCT01290471 - Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors Phase 1