NCT02675491 - Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors | Crick

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

15

Conditions

Advanced Solid Malignant Tumors

Interventions

DS-6051bDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (3)

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Kinki University Hospital

Osaka, Japan

National Cancer Center Hospital

Tokyo, Japan

Outcomes

Primary Outcomes

number and severity of adverse events

number and severity of treatment emergent adverse events

Time frame: Day 1 through 28 days after last dose

Secondary Outcomes

Cmax of DS-6051a

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.

Time frame: Days 1 and 15 of Cycle 1

Tmax of DS-6051a

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.

Time frame: Days 1 and 15 of Cycle 1

AUC of DS-6051a

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.

Time frame: Days 1 and 15 of Cycle 1

clearance (CL/F) of DS-6051a

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.

Time frame: Days 1 and 15 of Cycle 1

Number of participants with dose-limiting toxicities

to determine maximum tolerated dose/recommended phase 2 dose

Time frame: 21 days following the first dose of treatment