A Study of TAS-120 in Patients With Advanced Solid Tumors
NCT ID: NCT02052778
Last Updated: 2025-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
407 participants
INTERVENTIONAL
2014-07-21
2024-10-22
Brief Summary
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1. Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib.
2. Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary central nervous system tumors, urothelial carcinoma, breast cancer, gastric cancer.
3. Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Dose Escalation: QOD Dosing: 8 mg
Participants with or without fibroblast growth factor \[FGF\]/fibroblast growth factor receptor \[FGFR\] gene abnormalities received orally TAS-120 8 milligrams (mg) orally every other day (QOD; Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QOD Dosing: 16 mg
Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 16 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QOD Dosing: 24 mg
Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 24 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QOD Dosing: 36 mg
Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 36 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QOD Dosing: 56 mg
Participants with FGF/FGFR gene abnormalities received orally TAS-120 56 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QOD Dosing: 80 mg
Participants with FGF/FGFR gene abnormalities received orally TAS-120 80 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QOD Dosing: 120 mg
Participants with FGF/FGFR gene abnormalities received orally TAS-120 120 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QOD Dosing: 160 mg
Participants with FGF/FGFR gene abnormalities received orally TAS-120 160 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QOD Dosing: 200 mg
Participants with FGF/FGFR gene abnormalities received orally TAS-120 200 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QD Dosing: 4 mg
Participants with or without FGF/FGFR gene abnormalities received a dose between 4 mg orally once daily (QD) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QD Dosing: 8 mg
Participants with or without FGF/FGFR gene abnormalities received a dose between 8 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QD Dosing: 16 mg
Participants with or without FGF/FGFR gene abnormalities received a dose between 16 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QD Dosing: 20 mg
Participants with or without FGF/FGFR gene abnormalities received a dose between 20 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Escalation: QD Dosing: 24 mg
Participants with or without FGF/FGFR gene abnormalities received a dose between 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Expansion Cohort 1
Participants with intra-hepatic or extrahepatic cholangiocarcinoma (iCCA or eCCA) harboring FGFR2 gene fusions or rearrangements and who were treated or not treated with prior FGFR inhibitors received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Expansion: Cohort 2
Participants with primary central nervous system (CNS) tumors harboring FGFR gene fusions or FGFR1 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Expansion: Cohort 3
Participants with advanced urothelial carcinoma harboring FGFR3 gene fusions or FGFR3 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Expansion: Cohort 4
Participants with breast or gastric cancer with harboring FGFR2 amplification received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1:Dose Expansion: Cohort 5
Participants with tumor types harboring FGFR gene fusions or activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Expansion: Cohort 6
Participants who were not included in Cohorts 1 to 5 received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Expansion: Sub-cohort 1
Participants with iCCA who were enrolled prior to the confirmation of the recommended Phase 2 dose (RP2D) received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 1: Dose Expansion: Sub-cohort 2
Participants with other tumor types who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Phase 2
Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Futibatinib
oral once daily dosing, 21-day cycle
Interventions
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Futibatinib
oral once daily dosing, 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years of age
3. Has histologically or cytologically confirmed, locally advanced or metastatic cancer
4. The following specific criteria for each study portion
Phase 1 (Dose Escalation):
* Patients with any type of solid tumor
* Disease progression following standard therapies or intolerant to prior standard therapies
Phase 1 (Dose Expansion)
* Have at least one FGF/FGFR aberration
* Disease progression following standard therapies or were intolerant to prior standard therapies (including prior FGFR inhibitors).
* Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or Response Assessment in Neuro-Oncology criteria (2010) for brain tumors.
* Patients with any of the following tumor types
* Patients with intrahepatic or extrahepatic CCA harboring FGFR2 gene fusions or other FGFR2 aberrations
* Patients with primary CNS tumors
* Patients with advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
* Patients with breast cancer or gastric cancer
* Patients with other solid tumor types harboring FGFR gene fusions or activating mutations
* Patients with solid tumor types and other FGF/FGFR alterations not listed above
Phase 2
* Patients with iCCA and FGFR2 gene rearrangements (incl fusions)
* Have been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy
* Must have documentation of radiographic progression of disease
* No prior FGFR inhibitor
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. Adequate organ function.
Exclusion Criteria
2. History and/or current evidence of clinically significant ectopic mineralization/calcification.
3. History and/or current evidence of clinically significant retinal disorder
4. A serious illness or medical condition(s)
5. Pregnant or breast-feeding female
18 Years
ALL
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic (AZ)
Scottsdale, Arizona, United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center. Mission Bay
San Francisco, California, United States
Cancer Treatment Centers of America
Newnan, Georgia, United States
Cancer Treatment Centers of America Zion, IL
Zion, Illinois, United States
The University of Kansas Cancer Center
Fairway, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institution
Boston, Massachusetts, United States
Wayne State Universtity (Karmanos Cancer Institute)
Detroit, Michigan, United States
Mayo Clinic (MN)
Rochester, Minnesota, United States
New Mexico Cancer Care Alliancer
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sidney Kimmel Cancer Center at Jefferson
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Greenville Health System ITOR,Clinical Research Unit
Greenville, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Mary Crowley Cancer Research - Medical City
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah, Huntsman Cancer Hospital
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Virginia Mason Cancer Center
Seattle, Washington, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Melbourne Hospital
Melbourne, , Australia
Sunnybrook Research Institue
Toronto, , Canada
Centre Léon Bérard Bât
Lyon, Cedex, France
Institut Bergonie
Bordeaux, , France
Hospices Civils de Lyon
Bron, , France
Pitié-Salpêtrière Hospital
Paris, , France
Rennes, Centre Eugène Marquis
Rennes, , France
Institute Goustave-Roussy-DITEP
Villejuif, , France
University Hospital Essen, West German Cancer Center, Department of Medical Oncology
Essen, , Germany
The Chinese University of Hong Kong
Shatin, , Hong Kong
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, , Italy
UOC Oncologia Medica 1 I"V - Istituto Oncologico Veneto - IRCCS
Padua, , Italy
Hokkaido University Hospital
Hokkaido, , Japan
Kyoto University Hospital, Department of Clinical Pharmacology and Therapeutics
Kyoto, , Japan
Tohoku University Hospital
Miyagi, , Japan
Osaka International Cancer Institute
Osaka, , Japan
National Cancer Center Hospital
Tokyo, , Japan
University Hospital Jenna
Jenna, , Netherlands
Yonsei University, Severance Hospital (Seoul)
Seoul, , South Korea
ASAN Medical Center (Seoul)
Seoul, , South Korea
Samsung Medical Center (Seoul)
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Val D'Hebron University Hospital
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona,
Barcelona, , Spain
University Hospital Ramón y Cajal
Madrid, , Spain
Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
University College London Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klumpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Komatsu Y, Ahn DH, Epstein RS, Halim AB, Wacheck V, He Y, Liu M, Benhadji KA, Bridgewater JA; FOENIX-CCA2 Study Investigators. Plain language summary of the FOENIX-CCA2 study: futibatinib for people with advanced bile duct cancer. Future Oncol. 2024;20(36):2811-2822. doi: 10.1080/14796694.2024.2364504. Epub 2024 Jun 17.
DiPeri TP, Zhao M, Evans KW, Varadarajan K, Moss T, Scott S, Kahle MP, Byrnes CC, Chen H, Lee SS, Halim AB, Hirai H, Wacheck V, Kwong LN, Rodon J, Javle M, Meric-Bernstam F. Convergent MAPK pathway alterations mediate acquired resistance to FGFR inhibitors in FGFR2 fusion-positive cholangiocarcinoma. J Hepatol. 2024 Feb;80(2):322-334. doi: 10.1016/j.jhep.2023.10.041. Epub 2023 Nov 14.
Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klumpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Mitchell EP, Komatsu Y, Masuda K, Ahn D, Epstein RS, Halim AB, Fu Y, Salimi T, Wacheck V, He Y, Liu M, Benhadji KA, Bridgewater JA; FOENIX-CCA2 Study Investigators. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma. N Engl J Med. 2023 Jan 19;388(3):228-239. doi: 10.1056/NEJMoa2206834.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-004810-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TPU-TAS-120-101
Identifier Type: -
Identifier Source: org_study_id
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