Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
NCT ID: NCT05727176
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2023-07-05
2026-12-31
Brief Summary
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Detailed Description
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* Patients will receive futibatinib at an oral dose of 16 mg, administered daily (QD) on every day of a 21-day cycle.
* Patients will receive futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle.
Patients may continue to receive continuous futibatinib until documentation of progressive disease (PD) per RECIST 1.1, or until other withdrawal criteria are met, whichever comes first.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm A
TAS-120 (20mg) tablets, oral; 21-day cycle
TAS-120
TAS-120 is an oral FGFR inhibitor
Treatment Arm B
TAS-120 (16mg) tablets, oral; 21-day cycle
TAS-120
TAS-120 is an oral FGFR inhibitor
Interventions
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TAS-120
TAS-120 is an oral FGFR inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement
3. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
4. Documentation of radiographic disease progression on the most recent prior therapy
5. Measurable disease
6. performance status 0 or 1
7. Adequate organ function
Exclusion Criteria
2. Current evidence of clinically significant retinal disorder
3. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:
1. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
2. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
3. Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer
4. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.
5. Patients with prior FGFR-directed therapy
4. A serious illness or medical condition(s) including (but not limited to) the following:
1. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month
2. Known acute systemic infection
3. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV New York Heart Association \[NYHA\] Classification) within the previous 2 months; if \>2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms
4. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.
5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study.
5. Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.
6. Pregnant or lactating female.
7. Known hypersensitivity or severe reaction to futibatinib or its excipients.
18 Years
ALL
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California San Diego UCSD - Moores Cancer Center
La Jolla, California, United States
Tampa General Hospital Cancer Institute
Tampa, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Texas Oncology
Abilene, Texas, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Texas Oncology Methodist DFW
Dallas, Texas, United States
Texas Onc Methodist (Charlton)
Dallas, Texas, United States
Texas Oncology - Northeast
Denton, Texas, United States
Center for Oncology and Blood Disorders
Houston, Texas, United States
Hospital Britanico
Buenos Aires, , Argentina
CEMIC
CABA, , Argentina
Sanatorio de la Mujer
Rosario, , Argentina
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
Sydney, New South Wales, Australia
Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center
Melbourne, Victoria, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Instituto do Cancer do Estado de Sao Paulo
Cerqueira César, , Brazil
IOP - Instituto de Oncologia do Parana
Curitiba, , Brazil
Hospital Erasto Gaertner
Curitiba, , Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, , Brazil
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
São Paulo, , Brazil
Grand River Hospital - Grand River Regional Cancer Centre (GRRCC)
Kitchener, OH, Canada
Sunnybrook Health Sciences Center
Toronto, OH, Canada
University of Toronto
Toronto, OH, Canada
McGill University Health Center
Montreal, Quebec, Canada
Guangdong Provincial People's Hospitall
Guangzhou, Guangdong, China
Harbin Medical University - Cancer Hospital
Harbin, Heilongjiang, China
Jiangsu Provance Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
Shandong University - Shandong Cancer Hospital
Jinan, Shandong, China
Zhongahan Hospital Fudan unversity
Shanghai, Shanghai Municipality, China
West China Hospital- Sichuan University
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
Shanghai, , China
Tongji University Shanghai East Hospital
Shanghai, , China
The University of Hong Kong
Hong Kong Island, , Hong Kong
The Chinese University of Hong Kong Prince of Wales Hospital
New Territories, , Hong Kong
Policlinico S. Orsola-Malpighi
Bologna, , Italy
IRCCS Humanitas Research Hospital
Rozzano, , Italy
AOUI Verona - Ospedale Borgo Roma
Verona, , Italy
Tohoku University Hospital
Sendai, Miyagi, Japan
National Cancer Center Hospital East
Kashiwa-Shi, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Nagoya University Hospital
Nagoya, , Japan
Osaka Metropolitan University Hospital
Osaka-Fu, , Japan
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
Koszalin, , Poland
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
Lublin, , Poland
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
Otwock, , Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
Warsaw, , Poland
Fundação Champalimaud
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
Lisbon, , Portugal
Inje University Haeundae Paik Hospital
Busan, , South Korea
Dong-A University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
CHA Bundang Medical Center
Seongnam, , South Korea
Yonsei University Health System - Severance Hospital
Seoul, , South Korea
The Catholic University of Korea, St. Mary's Hospital
Seoul, , South Korea
Hospital Vall d'Hebron
Barcelona, , Spain
Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)
Madrid, , Spain
Hospital Universitario Fundación Jimenez Díaz
Madrid, , Spain
Hospital Universitario 12 de octubre
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Susumu Eguchi
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Other Identifiers
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2023-503665-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-9400
Identifier Type: OTHER
Identifier Source: secondary_id
TAS-120-205
Identifier Type: -
Identifier Source: org_study_id