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RECRUITING

NCT05727176

PHASE2

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Sponsor: Taiho Oncology, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.

Official title: Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-07-05

Completion Date

2026-12

Last Updated

2025-12-29

Healthy Volunteers

Conditions

Advanced Cholangiocarcinoma FGFR2 Fusions Gene Rearrangement

Interventions

DRUG

TAS-120

TAS-120 is an oral FGFR inhibitor

Inclusion Criteria: 1. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma. 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: 1. History or current evidence of calcium and phosphate homeostasis disorder 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.

Locations (65)

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

Clinical Research Directory

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (65)