A Study of TAS-120 in Patients With Advanced Solid 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: NCT02052778 |
Recruitment Status :
Active, not recruiting
First Posted : February 3, 2014
Last Update Posted : January 10, 2022
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Sponsor:
Taiho Oncology, Inc.
Information provided by (Responsible Party):
Taiho Oncology, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | January 23, 2014 | ||||
First Posted Date ICMJE | February 3, 2014 | ||||
Last Update Posted Date | January 10, 2022 | ||||
Actual Study Start Date ICMJE | July 2014 | ||||
Actual Primary Completion Date | May 29, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of TAS-120 in Patients With Advanced Solid Tumors | ||||
Official Title ICMJE | Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations | ||||
Brief Summary | This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts:
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Futibatinib
oral once daily dosing, 21-day cycle
Other Name: TAS-120
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Study Arms ICMJE |
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Publications * | Bahleda R, Meric-Bernstam F, Goyal L, Tran B, He Y, Yamamiya I, Benhadji KA, Matos I, Arkenau HT. Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors. Ann Oncol. 2020 Oct;31(10):1405-1412. doi: 10.1016/j.annonc.2020.06.018. Epub 2020 Jul 2. | ||||
* 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 | ||||
Actual Enrollment ICMJE |
386 | ||||
Original Estimated Enrollment ICMJE |
835 | ||||
Estimated Study Completion Date ICMJE | June 30, 2022 | ||||
Actual Primary Completion Date | May 29, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 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 | Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Spain, Taiwan, United Kingdom, United States | ||||
Removed Location Countries | Portugal | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT02052778 | ||||
Other Study ID Numbers ICMJE | TPU-TAS-120-101 2013-004810-16 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Taiho Oncology, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Taiho Oncology, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Taiho Oncology, Inc. | ||||
Verification Date | January 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |