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

• ClinicalTrials.gov Identifier: NCT02675491
• Recruitment Status: Active, not recruiting
• First Posted: February 5, 2016
• Last Update Posted: January 13, 2021
• Sponsor: Daiichi Sankyo Co., Ltd.
• Information provided by (Responsible Party): Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Tracking Information

• First Submitted Date: February 2, 2016
• First Posted Date: February 5, 2016
• Last Update Posted Date: January 13, 2021
• Study Start Date: February 2016
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 3, 2016)

number and severity of adverse events [ Time Frame: Day 1 through 28 days after last dose ]

number and severity of treatment emergent adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 3, 2016)

• Cmax of DS-6051a [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 21 days following the first dose of treatment ]
  to determine maximum tolerated dose/recommended phase 2 dose

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors
• Official Title: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Solid Malignant Tumors

Intervention

Drug: DS-6051b

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

Study Arms

Experimental: DS-6051b

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

Intervention: Drug: DS-6051b

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: February 13, 2017): 15
• Original Estimated Enrollment (submitted: February 3, 2016): 9
• Estimated Study Completion Date: April 2022
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT02675491
• Other Study ID Numbers: DS6051-A-J102; 153111 ( Registry Identifier: JAPIC CTI )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: Analytic Code
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• URL: https://vivli.org/ourmember/daiichi-sankyo/

• Responsible Party: Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
• Study Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborators: Not Provided

Investigators

• Study Director: Global Clinical Leader; Daiichi Sankyo, Inc.

• PRS Account: Daiichi Sankyo, Inc.
• Verification Date: January 2021