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

Daiichi Sankyo

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Malignant Tumors

Treatments

Drug: DS-6051b

Study type

Interventional

Funder types

Industry

Identifiers

NCT02675491

DS6051-A-J102

153111 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available.
An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Exclusion criteria

Previously had or currently has any of the following diseases:

Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.

Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
Severe or uncontrolled concomitant disease.
Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.