Actively Recruiting
Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements
Led by Taiho Oncology, Inc. · Updated on 2026-05-28
120
Participants Needed
65
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of futibatinib, an oral FGFR inhibitor, in patients with advanced cholangiocarcinoma (CCA) that has FGFR2 gene fusions or rearrangements. This Phase 2, open-label, multinational, randomized study aims to confirm the clinical benefit of a 20 mg dose and assess the safety and efficacy of a 16 mg dose in patients who have previously received treatment for their cancer. Participants are randomly assigned in equal numbers to receive either 16 mg or 20 mg of futibatinib daily in a 21-day cycle. Treatment continues until the disease progresses according to specific criteria or until other withdrawal conditions are met. The study compares these two dose levels to understand their impact on the disease. During the study, participants undergo regular assessments including imaging to measure tumor response, laboratory tests to monitor health, and quality of life questionnaires. Researchers will evaluate outcomes such as the overall response rate, duration of response, progression-free survival, overall survival, and treatment-emergent side effects. These evaluations continue up to 12 months after the study completion to gather comprehensive safety and efficacy data.
CONDITIONS
Brief Title
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic or extrahepatic cholangiocarcinoma
- Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangements
- Received at least one prior systemic gemcitabine and platinum-based regimen for cholangiocarcinoma
- Radiographic disease progression on the most recent prior therapy
- Measurable disease
- Performance status 0 or 1
- Adequate organ function
You will not qualify if you...
- History or current evidence of calcium and phosphate homeostasis disorder
- Current evidence of clinically significant retinal disorder
- Major surgery within the previous 4 weeks or radiotherapy within 2 to 4 weeks depending on the field
- Locoregional therapy such as TACE, SIRT, or ablation within 4 weeks
- Non-investigational anticancer therapy within 3 weeks or unresolved side effects prior to futibatinib
- Targeted therapy, immunotherapy, or investigational agents within 3 weeks or 5 half-lives prior to futibatinib
- Prior FGFR-directed therapy
- Serious illness including brain metastasis unless stable for at least 1 month, acute infection, recent severe cardiac events within 2 months, significant gastrointestinal disorders affecting absorption, or other severe medical or psychiatric conditions
- Known progressing additional malignancy requiring active treatment except certain prior or concurrent cancers
- Pregnant or lactating female
- Known hypersensitivity or severe reaction to futibatinib or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Continuous 21-day cycles until disease progression or withdrawal
Participants receive futibatinib orally at either 16 mg or 20 mg daily in 21-day cycles until disease progression or other withdrawal criteria are met.
Daily oral dosing with regular clinical visits during treatment
Trial Site Locations
Total: 65 locations
1
University of California San Diego UCSD - Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
2
Tampa General Hospital Cancer Institute
Tampa, Florida, United States, 33606
Actively Recruiting
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
4
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Withdrawn
5
Texas Oncology
Abilene, Texas, United States, 79606-5208
Actively Recruiting
6
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Actively Recruiting
7
Texas Oncology Methodist DFW
Dallas, Texas, United States, 75230
Actively Recruiting
8
Texas Onc Methodist (Charlton)
Dallas, Texas, United States, 75237
Actively Recruiting
9
Texas Oncology - Northeast
Denton, Texas, United States, 76201
Actively Recruiting
10
Center for Oncology and Blood Disorders
Houston, Texas, United States, 77030
Withdrawn
11
Hospital Britanico
Buenos Aires, Argentina, AEB1280
Actively Recruiting
12
CEMIC
CABA, Argentina, 1431
Actively Recruiting
13
Sanatorio de la Mujer
Rosario, Argentina, S2013
Actively Recruiting
14
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
Sydney, New South Wales, Australia, 2010
Actively Recruiting
15
Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center
Melbourne, Victoria, Australia, 3004
Actively Recruiting
16
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia, 6008
Actively Recruiting
17
Instituto do Cancer do Estado de Sao Paulo
Cerqueira César, Brazil, 01246-000
Actively Recruiting
18
IOP - Instituto de Oncologia do Parana
Curitiba, Brazil, 80530-010
Actively Recruiting
19
Hospital Erasto Gaertner
Curitiba, Brazil, 81520-060
Actively Recruiting
20
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
21
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
São Paulo, Brazil, 01508-010
Actively Recruiting
22
Grand River Hospital - Grand River Regional Cancer Centre (GRRCC)
Kitchener, OH, Canada, N2G 1G3
Actively Recruiting
23
Sunnybrook Health Sciences Center
Toronto, OH, Canada, M4M 3N5
Actively Recruiting
24
University of Toronto
Toronto, OH, Canada, M5G 2M9
Actively Recruiting
25
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
26
Guangdong Provincial People's Hospitall
Guangzhou, Guangdong, China, 510080
Actively Recruiting
27
Harbin Medical University - Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
28
Jiangsu Provance Hospital
Nanjing, Jiangsu, China, 212028
Not Yet Recruiting
29
Jilin Cancer Hospital
Changchun, Jilin, China, 130028
Actively Recruiting
30
Shandong University - Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
31
Zhongahan Hospital Fudan unversity
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
32
West China Hospital- Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
33
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
34
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
Shanghai, China, 200123
Actively Recruiting
35
Tongji University Shanghai East Hospital
Shanghai, China
Actively Recruiting
36
The University of Hong Kong
Hong Kong Island, Hong Kong, 999077
Actively Recruiting
37
The Chinese University of Hong Kong Prince of Wales Hospital
New Territories, Hong Kong, 999077
Actively Recruiting
38
Policlinico S. Orsola-Malpighi
Bologna, Italy, 40138
Actively Recruiting
39
IRCCS Humanitas Research Hospital
Rozzano, Italy, 20089
Actively Recruiting
40
AOUI Verona - Ospedale Borgo Roma
Verona, Italy, 37134
Actively Recruiting
41
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Withdrawn
42
National Cancer Center Hospital East
Kashiwa-Shi, Japan, 277-0882
Actively Recruiting
43
Nagasaki University Hospital
Nagasaki, Japan, 852-8501
Withdrawn
44
Nagoya University Hospital
Nagoya, Japan, 466-8560
Actively Recruiting
45
Osaka Metropolitan University Hospital
Osaka-Fu, Japan, 558-8585
Actively Recruiting
46
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
Koszalin, Poland, 75-581
Withdrawn
47
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
Lublin, Poland, 20-0920
Withdrawn
48
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
Otwock, Poland, 05-400
Actively Recruiting
49
Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
Warsaw, Poland, 02-034
Actively Recruiting
50
Fundação Champalimaud
Lisbon, Portugal, 1400-038
Actively Recruiting
51
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
52
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
53
Dong-A University Hospital
Busan, South Korea, 49201
Withdrawn
54
Kyungpook National University Hospital
Daegu, South Korea, 41944
Actively Recruiting
55
Gyeongsang National University Hospital
Jinju, South Korea, 52727
Actively Recruiting
56
CHA Bundang Medical Center
Seongnam, South Korea, 13532
Actively Recruiting
57
Yonsei University Health System - Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
58
The Catholic University of Korea, St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
59
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
60
Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
Barcelona, Spain, 08908
Actively Recruiting
61
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
62
Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)
Madrid, Spain, 28027
Actively Recruiting
63
Hospital Universitario Fundación Jimenez Díaz
Madrid, Spain, 28040
Actively Recruiting
64
Hospital Universitario 12 de octubre
Madrid, Spain, 28043
Actively Recruiting
65
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
Research Team
T
Taiho Oncology, INC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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