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
COMPLETED
La Jolla
Florida
Tampa General Hospital Cancer Institute
WITHDRAWN
Tampa
Michigan
Henry Ford Health System
COMPLETED
Detroit
Ohio
Gabrail Cancer Center Research
WITHDRAWN
Canton
Texas
Texas Oncology
COMPLETED
Abilene
Texas Onc Methodist (Charlton)
COMPLETED
Dallas
Texas Oncology Methodist DFW
COMPLETED
Dallas
The Liver Institute at Methodist Dallas Medical Center
COMPLETED
Dallas
Texas Oncology - Northeast
COMPLETED
Denton
Center for Oncology and Blood Disorders
WITHDRAWN
Houston
Other Locations
Argentina
Hospital Britanico
COMPLETED
Buenos Aires
CEMIC
COMPLETED
Caba
Sanatorio de la Mujer
WITHDRAWN
Rosario
Australia
Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center
COMPLETED
Melbourne
St John of God Subiaco Hospital
COMPLETED
Subiaco
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
COMPLETED
Sydney
Brazil
Instituto do Cancer do Estado de Sao Paulo
COMPLETED
Cerqueira César
Hospital Erasto Gaertner
WITHDRAWN
Curitiba
IOP - Instituto de Oncologia do Parana
COMPLETED
Curitiba
Hospital de Base de Sao Jose do Rio Preto
COMPLETED
São José Do Rio Preto
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
COMPLETED
São Paulo
Canada
Grand River Hospital - Grand River Regional Cancer Centre (GRRCC)
WITHDRAWN
Kitchener
McGill University Health Center
WITHDRAWN
Montreal
Sunnybrook Health Sciences Center
WITHDRAWN
Toronto
University of Toronto
COMPLETED
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
RECRUITING
Nanjing
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
RECRUITING
Shanghai
Tongji University Shanghai East Hospital
RECRUITING
Shanghai
Zhongahan Hospital Fudan unversity
RECRUITING
Shanghai
Hong Kong Special Administrative Region
The University of Hong Kong
WITHDRAWN
Hong Kong Island
The Chinese University of Hong Kong Prince of Wales Hospital
COMPLETED
New Territories
Italy
Policlinico S. Orsola-Malpighi
COMPLETED
Bologna
IRCCS Humanitas Research Hospital
COMPLETED
Rozzano
AOUI Verona - Ospedale Borgo Roma
COMPLETED
Verona
Japan
National Cancer Center Hospital East
COMPLETED
Kashiwa-shi
Nagasaki University Hospital
WITHDRAWN
Nagasaki
Nagoya University Hospital
COMPLETED
Nagoya
Osaka Metropolitan University Hospital
COMPLETED
Osaka-fu
Tohoku University Hospital
WITHDRAWN
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.
COMPLETED
Otwock
Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
COMPLETED
Warsaw
Portugal
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
WITHDRAWN
Lisbon
Fundação Champalimaud
WITHDRAWN
Lisbon
Republic of Korea
Dong-A University Hospital
WITHDRAWN
Busan
Inje University Haeundae Paik Hospital
COMPLETED
Busan
Kyungpook National University Hospital
WITHDRAWN
Daegu
Gyeongsang National University Hospital
WITHDRAWN
Jinju
CHA Bundang Medical Center
COMPLETED
Seongnam
The Catholic University of Korea, St. Mary's Hospital
COMPLETED
Seoul
Yonsei University Health System - Severance Hospital
COMPLETED
Seoul
Spain
Hospital Vall d'Hebron
COMPLETED
Barcelona
Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
COMPLETED
Barcelona
Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)
WITHDRAWN
Madrid
Hospital General Universitario Gregorio Maranon
COMPLETED
Madrid
Hospital Universitario 12 de octubre
COMPLETED
Madrid
Hospital Universitario Fundación Jimenez Díaz
COMPLETED
Madrid
Clinica Universidad de Navarra
COMPLETED
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.