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

Sponsor

Daiichi Sankyo Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02675491

Collaborator

(none)

Enrollment

Locations

Arm

70.9

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Malignant Tumors	Drug: DS-6051b	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Dec 27, 2021

Actual Study Completion Date :

Dec 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DS-6051b Drug: DS-6051b 400 mg or 800 mg daily	Drug: DS-6051b Drug: DS-6051b 400 mg or 800 mg daily

Arm

Intervention/Treatment

Experimental: DS-6051b

Drug: DS-6051b 400 mg or 800 mg daily

Drug: DS-6051b

Drug: DS-6051b 400 mg or 800 mg daily

Outcome Measures

Primary Outcome Measures

number and severity of adverse events [Day 1 through 28 days after last dose]
number and severity of treatment emergent adverse events

Secondary Outcome Measures

Cmax of DS-6051a [Days 1 and 15 of Cycle 1]
Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1.
Tmax of DS-6051a [Days 1 and 15 of Cycle 1]
Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1.
AUC of DS-6051a [Days 1 and 15 of Cycle 1]
Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1.
clearance (CL/F) of DS-6051a [Days 1 and 15 of Cycle 1]
Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1.
Number of participants with dose-limiting toxicities [21 days following the first dose of treatment]
to determine maximum tolerated dose/recommended phase 2 dose

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.