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

Advanced Solid Malignant Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675491
• Other study ID #: DS6051-A-J102
• Secondary ID: 153111
• Status: Completed
• Phase: Phase 1
• Start date: February 2016
• Est. completion date: December 28, 2021

Study information

• Verified date: May 2022
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 28, 2021
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Malignant Tumors
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Kinki University Hospital	Osaka
Japan	National Cancer Center Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number and severity of adverse events	number and severity of treatment emergent adverse events	Day 1 through 28 days after last dose
Secondary	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.	Days 1 and 15 of Cycle 1
Secondary	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.	Days 1 and 15 of Cycle 1
Secondary	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.	Days 1 and 15 of Cycle 1
Secondary	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.	Days 1 and 15 of Cycle 1
Secondary	Number of participants with dose-limiting toxicities	to determine maximum tolerated dose/recommended phase 2 dose	21 days following the first dose of treatment