Trial record 2 of 3 for:
DS6051
Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02675491 |
Recruitment Status :
Active, not recruiting
First Posted : February 5, 2016
Last Update Posted : January 13, 2021
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Sponsor:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
Tracking Information | |||||||||||||||||||||
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First Submitted Date ICMJE | February 2, 2016 | ||||||||||||||||||||
First Posted Date ICMJE | February 5, 2016 | ||||||||||||||||||||
Last Update Posted Date | January 13, 2021 | ||||||||||||||||||||
Study Start Date ICMJE | February 2016 | ||||||||||||||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
number and severity of adverse events [ Time Frame: Day 1 through 28 days after last dose ] number and severity of treatment emergent adverse events
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||
Brief Title ICMJE | Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors | ||||||||||||||||||||
Official Title ICMJE | 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 ICMJE | Interventional | ||||||||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Malignant Tumors | ||||||||||||||||||||
Intervention ICMJE | Drug: DS-6051b
Drug: DS-6051b 400 mg or 800 mg daily
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Study Arms ICMJE | Experimental: DS-6051b
Drug: DS-6051b 400 mg or 800 mg daily
Intervention: Drug: DS-6051b
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Publications * | Not Provided | ||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||
Estimated Enrollment ICMJE |
15 | ||||||||||||||||||||
Original Estimated Enrollment ICMJE |
9 | ||||||||||||||||||||
Estimated Study Completion Date ICMJE | April 2022 | ||||||||||||||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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.
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
Listed Location Countries ICMJE | Japan | ||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||
Administrative Information | |||||||||||||||||||||
NCT Number ICMJE | NCT02675491 | ||||||||||||||||||||
Other Study ID Numbers ICMJE | DS6051-A-J102 153111 ( Registry Identifier: JAPIC CTI ) |
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Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ) | ||||||||||||||||||||
Study Sponsor ICMJE | Daiichi Sankyo Co., Ltd. | ||||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Daiichi Sankyo, Inc. | ||||||||||||||||||||
Verification Date | January 2021 | ||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |