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

Phase 1

Completed

• Conditions: Advanced Solid Malignant Tumors
• Interventions: Drug: DS-6051b

• Registration Number: NCT02675491
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

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.

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 Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-05
• Study Start: 2016-02-10
• Primary Completion: 2021-12-27
• Study Completion: 2021-12-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DS-6051b	DS-6051b	Drug: DS-6051b 400 mg or 800 mg daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Number of participants with dose-limiting toxicities	21 days following the first dose of treatment	to determine maximum tolerated dose/recommended phase 2 dose
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.

Trial Locations

Locations (3)

National Hospital Organization Kyushu Cancer Center; 🇯🇵 Fukuoka, Japan

Kinki University Hospital; 🇯🇵 Osaka, Japan

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan