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

NCT ID: NCT02675491

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-10

Study Completion Date

2021-12-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Advanced Solid Malignant Tumors

Keywords

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Advanced solid tumor DS-6051b ROS1 NTRK refractory to standard therapy no standard therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DS-6051b

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

Group Type EXPERIMENTAL

DS-6051b

Intervention Type DRUG

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

Interventions

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DS-6051b

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Site Status

Kinki University Hospital

Osaka, , Japan

Site Status

National Cancer Center Hospital

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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153111

Identifier Type: REGISTRY

Identifier Source: secondary_id

DS6051-A-J102

Identifier Type: -

Identifier Source: org_study_id