Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements
Status: Recruiting
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
• Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement
• Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
• Documentation of radiographic disease progression on the most recent prior therapy
• Measurable disease
• performance status 0 or 1
• Adequate organ function
Locations
United States
California
University of California San Diego UCSD - Moores Cancer Center
RECRUITING
La Jolla
Florida
Tampa General Hospital Cancer Institute
RECRUITING
Tampa
Michigan
Henry Ford Health System
RECRUITING
Detroit
Ohio
Gabrail Cancer Center Research
WITHDRAWN
Canton
Texas
Texas Oncology
RECRUITING
Abilene
Texas Onc Methodist (Charlton)
RECRUITING
Dallas
Texas Oncology Methodist DFW
RECRUITING
Dallas
The Liver Institute at Methodist Dallas Medical Center
RECRUITING
Dallas
Texas Oncology - Northeast
RECRUITING
Denton
Center for Oncology and Blood Disorders
WITHDRAWN
Houston
Other Locations
Argentina
Hospital Britanico
RECRUITING
Buenos Aires
CEMIC
RECRUITING
Caba
Sanatorio de la Mujer
RECRUITING
Rosario
Australia
Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center
RECRUITING
Melbourne
St John of God Subiaco Hospital
RECRUITING
Subiaco
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
RECRUITING
Sydney
Brazil
Instituto do Cancer do Estado de Sao Paulo
RECRUITING
Cerqueira César
Hospital Erasto Gaertner
RECRUITING
Curitiba
IOP - Instituto de Oncologia do Parana
RECRUITING
Curitiba
Hospital de Base de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
RECRUITING
São Paulo
Canada
Grand River Hospital - Grand River Regional Cancer Centre (GRRCC)
RECRUITING
Kitchener
McGill University Health Center
RECRUITING
Montreal
Sunnybrook Health Sciences Center
RECRUITING
Toronto
University of Toronto
RECRUITING
Toronto
China
Jilin Cancer Hospital
RECRUITING
Changchun
West China Hospital- Sichuan University
RECRUITING
Chengdu
Guangdong Provincial People's Hospitall
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University
RECRUITING
Hangzhou
Harbin Medical University - Cancer Hospital
RECRUITING
Harbin
Shandong University - Shandong Cancer Hospital
RECRUITING
Jinan
Jiangsu Provance Hospital
NOT_YET_RECRUITING
Nanjing
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
RECRUITING
Shanghai
Tongji University Shanghai East Hospital
RECRUITING
Shanghai
Zhongahan Hospital Fudan unversity
NOT_YET_RECRUITING
Shanghai
Hong Kong Special Administrative Region
The University of Hong Kong
RECRUITING
Hong Kong Island
The Chinese University of Hong Kong Prince of Wales Hospital
RECRUITING
New Territories
Italy
Policlinico S. Orsola-Malpighi
RECRUITING
Bologna
IRCCS Humanitas Research Hospital
RECRUITING
Rozzano
AOUI Verona - Ospedale Borgo Roma
RECRUITING
Verona
Japan
National Cancer Center Hospital East
RECRUITING
Kashiwa-shi
Nagasaki University Hospital
RECRUITING
Nagasaki
Nagoya University Hospital
RECRUITING
Nagoya
Osaka Metropolitan University Hospital
RECRUITING
Osaka-fu
Tohoku University Hospital
RECRUITING
Sendai
Poland
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
WITHDRAWN
Koszalin
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
WITHDRAWN
Lublin
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
RECRUITING
Otwock
Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
RECRUITING
Warsaw
Portugal
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
RECRUITING
Lisbon
Fundação Champalimaud
RECRUITING
Lisbon
Republic of Korea
Dong-A University Hospital
WITHDRAWN
Busan
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Kyungpook National University Hospital
RECRUITING
Daegu
Gyeongsang National University Hospital
RECRUITING
Jinju
CHA Bundang Medical Center
RECRUITING
Seongnam
The Catholic University of Korea, St. Mary's Hospital
RECRUITING
Seoul
Yonsei University Health System - Severance Hospital
RECRUITING
Seoul
Spain
Hospital Vall d'Hebron
RECRUITING
Barcelona
Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
RECRUITING
Barcelona
Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario 12 de octubre
RECRUITING
Madrid
Hospital Universitario Fundación Jimenez Díaz
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Contact Information
Primary
Taiho Oncology, INC
medicalinformation@taihooncology.com
+1 844-878-2446
Time Frame
Start Date: 2023-07-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
Experimental: Treatment Arm A
TAS-120 (20mg) tablets, oral; 21-day cycle
Experimental: Treatment Arm B
TAS-120 (16mg) tablets, oral; 21-day cycle
Related Therapeutic Areas
Sponsors
Leads: Taiho Oncology, Inc.