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

Advanced Solid Malignant Tumors Clinical Trial

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

Status Completed

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

Clinical Trial Details

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

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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