RecruitingPhase 2NCT05727176

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

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

Sponsor

Taiho Oncology, Inc.

Enrollment

120 participants

Start Date

Jul 5, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Cholangiocarcinoma FGFR2 Fusions Gene Rearrangement

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the drug futibatinib for people with bile duct cancer (cholangiocarcinoma) that has a specific genetic change called an FGFR2 fusion or rearrangement. Futibatinib works by blocking this abnormal gene signal that drives cancer growth. **You may be eligible if...** - You have confirmed cholangiocarcinoma (bile duct cancer) that has spread or cannot be removed - Your tumor has an FGFR2 gene fusion or rearrangement - You have already received at least one round of standard chemotherapy (gemcitabine and platinum-based) - Your cancer has continued growing despite previous treatment **You may NOT be eligible if...** - Your cancer does not have an FGFR2 rearrangement - You have calcium or phosphate level problems in your blood - You have a serious eye condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTAS-120

TAS-120 is an oral FGFR inhibitor

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

View Full Details on ClinicalTrials.gov

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NCT05727176

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