Trial Title:
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
NCT ID:
NCT05727176
Condition:
Advanced Cholangiocarcinoma
FGFR2 Fusions
Gene Rearrangement
Conditions: Official terms:
Cholangiocarcinoma
Futibatinib
Conditions: Keywords:
Futibatinib
Advanced cholangiocarcinoma
cholangiocarcinoma
FGFR2
Fusion
Rearrangemen
TAS-120
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TAS-120
Description:
TAS-120 is an oral FGFR inhibitor
Arm group label:
Treatment Arm A
Arm group label:
Treatment Arm B
Other name:
Futibatinib
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.
Detailed description:
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. Eligible
patients will be randomized on a 1:1 basis to the following study arms:
- Patients will receive futibatinib at an oral dose of 16 mg, administered daily (QD)
on every day of a 21-day cycle.
- Patients will receive futibatinib at an oral dose of 20 mg, administered daily (QD)
on every day of a 21-day cycle.
Patients may continue to receive continuous futibatinib until documentation of
progressive disease (PD) per RECIST 1.1, or until other withdrawal criteria are met,
whichever comes first.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California San Diego UCSD - Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Contact:
Phone:
858-657-7000
Email:
aburgoyne@health.ucsd.edu
Investigator:
Last name:
Burgoyne Adam
Email:
Principal Investigator
Facility:
Name:
Tampa General Hospital Cancer Institute
Address:
City:
Tampa
Zip:
33606
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Phone:
888-734-5322
Email:
pphilip1@hfhs.org
Investigator:
Last name:
Philip Philip
Email:
Principal Investigator
Facility:
Name:
Gabrail Cancer Center Research
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Phone:
440-492-3345
Email:
nashgabrailmd@gabrailcancercenter.com
Investigator:
Last name:
Nashat Gabrail
Email:
Principal Investigator
Facility:
Name:
Texas Oncology
Address:
City:
Abilene
Zip:
79606-5208
Country:
United States
Status:
Recruiting
Contact:
Phone:
325-692-0188
Email:
anton.melnyk@usoncology.com
Investigator:
Last name:
Melynk Anton
Email:
Principal Investigator
Facility:
Name:
The Liver Institute at Methodist Dallas Medical Center
Address:
City:
Dallas
Zip:
75203
Country:
United States
Status:
Recruiting
Contact:
Phone:
214-947-4450
Email:
ParvezMantry@mhd.com
Investigator:
Last name:
Parvez Mantry
Email:
Principal Investigator
Facility:
Name:
Center for Oncology and Blood Disorders
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Email:
lhcamacho@cobd.us
Contact backup:
Phone:
+1 833-254-6829
Investigator:
Last name:
Camacho Luis
Email:
Principal Investigator
Facility:
Name:
CEMIC
Address:
City:
Caba
Zip:
1431
Country:
Argentina
Status:
Recruiting
Contact:
Phone:
+54 5299-0100
Email:
julieta.grasselli@gmail.com
Investigator:
Last name:
Julieta Grasselli
Email:
Principal Investigator
Facility:
Name:
Hospital Britanico
Address:
City:
Ciudad Autonoma de Buenos Aires
Zip:
AEB1280
Country:
Argentina
Status:
Recruiting
Contact:
Phone:
+54 4309-6400
Email:
lubq1@yahoo.com.ar
Investigator:
Last name:
Luciana Bella Quero
Email:
Principal Investigator
Facility:
Name:
Sanatorio de la Mujer
Address:
City:
Rosario
Zip:
S2013
Country:
Argentina
Status:
Recruiting
Contact:
Phone:
+54 640-5260
Email:
cristina_nasurdi@hotmail.com
Investigator:
Last name:
Cristina Nasurdi
Email:
Principal Investigator
Facility:
Name:
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
Address:
City:
Sydney
Zip:
2010
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Hao-Wen Sim
Email:
Principal Investigator
Facility:
Name:
Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Sanjeev Gill
Email:
Principal Investigator
Facility:
Name:
St John of God Subiaco Hospital
Address:
City:
Subiaco
Zip:
6008
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Instituto do Cancer do Estado de Sao Paulo
Address:
City:
Cerqueira César
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Contact:
Phone:
+55 11 9 9644-6112
Email:
marlene.salgado@hc.fm.usp.br
Investigator:
Last name:
Camila Motta Venchiarutti Moniz
Email:
Principal Investigator
Facility:
Name:
IOP - Instituto de Oncologia do Parana
Address:
City:
Curitiba
Zip:
80530-010
Country:
Brazil
Status:
Recruiting
Contact:
Phone:
+55 3207-9788
Email:
mariana.brandao@iop.com.br
Investigator:
Last name:
Luciano Semensato Biela
Email:
Principal Investigator
Facility:
Name:
Hospital Erasto Gaertner
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Recruiting
Contact:
Phone:
+55 3361-5195
Email:
andressaschuta@gmail.com
Investigator:
Last name:
Andressa Ribas
Email:
Principal Investigator
Facility:
Name:
Hospital de Base de Sao Jose do Rio Preto
Address:
City:
São José Do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Recruiting
Contact:
Phone:
+ 55 3201-5054
Email:
caldeira.kamylla@gmail.com
Investigator:
Last name:
Kathia Cristina Abadalla
Email:
Principal Investigator
Facility:
Name:
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
Address:
City:
São Paulo
Zip:
01508-010
Country:
Brazil
Status:
Recruiting
Contact:
Phone:
+55 11 98565-9911
Email:
tiago.felismino@accamargo.org.br
Investigator:
Last name:
Tiago Felismino
Email:
Principal Investigator
Facility:
Name:
Guangdong Provincial People's Hospitall
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
020-81884713
Email:
madong8005@126.com
Investigator:
Last name:
Dong Ma
Email:
Principal Investigator
Facility:
Name:
Harbin Medical University - Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13945095085
Email:
byxlcyj@126.com
Investigator:
Last name:
Yuxian Bai
Email:
Principal Investigator
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130028
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
0431-80596315
Email:
chengying@csco.org.cn
Investigator:
Last name:
Ying Cheng
Email:
Principal Investigator
Facility:
Name:
Shandong University - Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
15318816098
Email:
dangqi123456@126.com
Investigator:
Last name:
Qi Dang
Email:
Principal Investigator
Facility:
Name:
West China Hospital- Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
18980605963
Email:
caodan@wchscu.cn
Investigator:
Last name:
Dan Cao
Email:
Principal Investigator
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13605716662
Email:
shonco@sina.com
Investigator:
Last name:
Hongming Pan
Email:
Principal Investigator
Facility:
Name:
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
Address:
City:
Shanghai
Zip:
200123
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13661222111
Email:
lijin@csco.org.cn
Investigator:
Last name:
Jin Li
Email:
Principal Investigator
Facility:
Name:
Tongji University Shanghai East Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The University of Hong Kong
Address:
City:
Hong Kong Island
Zip:
999077
Country:
Hong Kong
Status:
Not yet recruiting
Facility:
Name:
The Chinese University of Hong Kong Prince of Wales Hospital
Address:
City:
New Territories
Zip:
999077
Country:
Hong Kong
Status:
Not yet recruiting
Facility:
Name:
Policlinico S. Orsola-Malpighi
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Phone:
0039 051 636 3838
Email:
giovanni.brandi@unibo.it
Investigator:
Last name:
Giovanni Brandi
Email:
Principal Investigator
Facility:
Name:
IRCCS Humanitas Research Hospital
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Phone:
0039 0282244573
Email:
lorenza.rimassa@hunimed.eu
Investigator:
Last name:
Lorenza Rimassa
Email:
Principal Investigator
Facility:
Name:
AOUI Verona - Ospedale Borgo Roma
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Contact:
Phone:
0039 045 812 8174
Phone ext:
8120
Email:
davide.melisi@gmail.com
Investigator:
Last name:
Davide Melisi
Email:
Principal Investigator
Facility:
Name:
Tohoku University Hospital
Address:
City:
Sendai
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Contact:
Phone:
0081 22 717 7000
Email:
maeda.shimpei@surg.med.tohoku.ac.jp
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-Shi
Zip:
277-0882
Country:
Japan
Status:
Recruiting
Contact:
Phone:
81958197200
Email:
kazuowat@east.ncc.go.jp
Investigator:
Last name:
Susumu Watanabe
Email:
Principal Investigator
Facility:
Name:
Nagasaki University Hospital
Address:
City:
Nagasaki-shi
Zip:
852-8501
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Susumu Eguchi
Phone:
0081 4 7133 1111
Email:
Sueguchi@nagasaki-uc.ac.jp
Investigator:
Last name:
Susumu Eguchi
Email:
Principal Investigator
Facility:
Name:
Nagoya University Hospital
Address:
City:
Nagoya-shi
Zip:
466-8560
Country:
Japan
Status:
Recruiting
Contact:
Phone:
0081 52 741-2111
Email:
tmzn@med.nagoya-u.ac.jp
Investigator:
Last name:
Takashi Mizuno
Email:
Principal Investigator
Facility:
Name:
Osaka Metropolitan University Hospital
Address:
City:
Osaka-Fu
Zip:
558-8585
Country:
Japan
Status:
Recruiting
Contact:
Phone:
0081 6 6645 2121
Email:
m1297198@msic.med.osaka-cu.ac.jp
Investigator:
Last name:
Hiroji Shinkawa
Email:
Principal Investigator
Facility:
Name:
Inje University Haeundae Paik Hospital
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Phone:
+82 51 797 0009
Email:
onelement@daum.net
Investigator:
Last name:
Il Hwan Kim
Email:
Principal Investigator
Facility:
Name:
Dong-A University Hospital
Address:
City:
Busan
Zip:
49201
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Phone:
82 825124028
Email:
drosy@dau.ac.kr
Investigator:
Last name:
Sung Yong Oh
Email:
Principal Investigator
Facility:
Name:
Kyungpook National University Hospital
Address:
City:
Daegu
Zip:
41944
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Phone:
82 200-5519
Email:
wytak@knu.ac.kr
Investigator:
Last name:
Won Young Tak
Email:
Principal Investigator
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju
Zip:
52727
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Phone:
+82 55 750 8053
Email:
newatp@naver.com
Investigator:
Last name:
Jung Hun Kang
Email:
Principal Investigator
Facility:
Name:
CHA Bundang Medical Center
Address:
City:
Seongnam
Zip:
13532
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Phone:
+82 31 780 5000
Email:
hongjaechon@gmail.com
Investigator:
Last name:
Hongjae Chon
Email:
Principal Investigator
Facility:
Name:
Yonsei University Health System - Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Phone:
+82 2 2228 8133
Email:
choihj@yuhs.ac
Investigator:
Last name:
Hye Jin Choi
Email:
Principal Investigator
Facility:
Name:
The Catholic University of Korea, St. Mary's Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Phone:
82 22586044
Email:
angelamd@catholic.ac.kr
Investigator:
Last name:
Myung Ah Lee
Email:
Principal Investigator
Facility:
Name:
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
Address:
City:
Koszalin
Zip:
75-581
Country:
Poland
Status:
Recruiting
Contact:
Phone:
0048 123516700
Email:
piotr.wysocki@uj.edu.pl
Investigator:
Last name:
Piotr Wysocki
Email:
Principal Investigator
Facility:
Name:
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
Address:
City:
Lublin
Zip:
20-0920
Country:
Poland
Status:
Recruiting
Contact:
Phone:
0048 600 238 474
Email:
achrzanowska@cozl.eu
Investigator:
Last name:
Agata Chrzanowska-Kapica
Email:
Principal Investigator
Facility:
Name:
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
Address:
City:
Otwock
Zip:
05-400
Country:
Poland
Status:
Recruiting
Contact:
Phone:
+48 227 103 035
Email:
cezary.szczylik@ecz-otwock.pl
Investigator:
Last name:
Cezary Szcylik
Email:
Principal Investigator
Facility:
Name:
Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
Address:
City:
Warszawa
Zip:
02-034
Country:
Poland
Status:
Recruiting
Contact:
Phone:
0048 506159219
Email:
lucjan.wrywicz@nio.gov.pl
Investigator:
Last name:
Lucjan Wyrwicz
Email:
Principal Investigator
Facility:
Name:
Fundação Champalimaud
Address:
City:
Lisboa
Zip:
1400-038
Country:
Portugal
Status:
Recruiting
Contact:
Phone:
00351 210 480 048
Phone ext:
4085
Email:
nuno.couto@fundacaochampalimaud.pt
Investigator:
Last name:
Nuno Couto
Email:
Principal Investigator
Facility:
Name:
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
Address:
City:
Lisbon
Zip:
1649-035
Country:
Portugal
Status:
Recruiting
Contact:
Phone:
00351 966 512 445
Email:
g.nogueiradacosta@gamil.com
Investigator:
Last name:
Catarina Abreu
Email:
Principal Investigator
Facility:
Name:
Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34-914-269394
Email:
tmacarulla@gmail.com
Investigator:
Last name:
Teresa Macarulla Mercadé
Email:
Principal Investigator
Facility:
Name:
Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
Address:
City:
Barcelona
Zip:
08908
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34-260
Email:
blaquente@iconcologia.net
Investigator:
Last name:
Berta Laquente Saez
Email:
Principal Investigator
Facility:
Name:
Hospital General Universitario Gregorio Maranon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Contact:
Phone:
0034 91 586 81 61
Investigator:
Last name:
Andres J. Munoz Martin
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Contact:
Phone:
0034913531920
Phone ext:
7501
Email:
mponz@unav.es
Investigator:
Last name:
Mariano Ponz-Sarvise
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Fundación Jimenez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Phone:
+34 648444925
Email:
angela.lamarca@quironsalud.es
Investigator:
Last name:
Angela Lamarca
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario 12 de octubre
Address:
City:
Madrid
Zip:
28043
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34-908-926
Email:
drcofi@hotmail.com
Investigator:
Last name:
Jorge Adeva Alfonso
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34-255 400
Email:
eecc@unav.es
Investigator:
Last name:
Mariano Ponz-Sarvise
Email:
Principal Investigator
Start date:
July 5, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Taiho Oncology, Inc.
Agency class:
Industry
Source:
Taiho Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05727176
