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Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement (FOENIX-CCA4)

Primary Purpose

Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAS-120
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cholangiocarcinoma focused on measuring Futibatinib, Advanced cholangiocarcinoma, cholangiocarcinoma, FGFR2, Fusion, Rearrangemen, TAS-120

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: History or current evidence of calcium and phosphate homeostasis disorder Current evidence of clinically significant retinal disorder Treatment with any of the following within the specified time frame prior to the first dose of futibatinib: 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 Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks 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 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. Patients with prior FGFR-directed therapy A serious illness or medical condition(s) including (but not limited to) the following: Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month Known acute systemic infection 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 Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib. 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. 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. Pregnant or lactating female. Known hypersensitivity or severe reaction to futibatinib or its excipients.

Sites / Locations

  • University of California San Diego UCSD - Moores Cancer Center
  • Henry Ford Health System
  • Gabrail Cancer Center ResearchRecruiting
  • Texas Oncology
  • The Liver Institute at Methodist Dallas Medical CenterRecruiting
  • Center for Oncology and Blood Disorders
  • CEMIC
  • Hospital Britanico
  • Sanatorio de la Mujer
  • Instituto do Cancer do Estado de Sao Paulo
  • IOP - Instituto de Oncologia do Parana
  • Hospital Erasto Gaertner
  • Hospital de Base de Sao Jose do Rio Preto
  • Shanghai East Hospital
  • Policlinico S. Orsola-Malpighi
  • IRCCS Humanitas Research Hospital
  • AOUI Verona - Ospedale Borgo Roma
  • National Cancer Center Hospital EastRecruiting
  • Nagasaki University Hospital
  • Nagoya University HospitalRecruiting
  • Osaka Metropolitan University Hospital
  • Inje University Haeundae Paik Hospital
  • Dong-A University HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Gyeongsang National University HospitalRecruiting
  • CHA Bundang Medical CenterRecruiting
  • Yonsei University Health System - Severance Hospital
  • The Catholic University of Korea, St. Mary's Hospital
  • Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
  • Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
  • Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
  • Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
  • Fundação Champalimaud
  • Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
  • Hospital Vall d'Hebron
  • Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario 12 de octubre
  • Clinica Universidad de Navarra
  • Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
  • Taichung Veterans General Hospital
  • Kaohsiung Medical University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Arm A

Treatment Arm B

Arm Description

TAS-120 (20mg) tablets, oral; 21-day cycle

TAS-120 (16mg) tablets, oral; 21-day cycle

Outcomes

Primary Outcome Measures

ORR by independent central review
defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on ICR

Secondary Outcome Measures

DoR by independent review
defined as time from the first documentation of response to the first documentation of objective tumor progression by ICR (per RECIST 1.1) or death due to any cause, whichever occurs first
PFS by independent review
defined as the time from date of randomization to the date of documentation of disease progression by ICR per RECIST (version 1.1, 2009) or date of death, whichever comes first
ORR per Investigator assessment
defined as proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST v1.1).
DoR per Investigator assessment
defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first
PFS per Investigator assessment
defined as the time from date of randomization to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first
OS
defined as the time from the date of randomization until the date of death due to any cause.
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0. including serious adverse events (SAEs) and dose modifications.
Change from Baseline in Quality of life as assessed by EORTC QLQ-C30
Change from Baseline in quality of life as assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Change from Baseline in Quality of life as assessed by EuroQol-5D (EQ-5D )
Change from Baseline in Quality of Life as Assessed by European Quality of Life - 5 Dimensions-3 Levels (EQ-5D-3L) Scale Score.

Full Information

First Posted
January 23, 2023
Last Updated
October 4, 2023
Sponsor
Taiho Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05727176
Brief Title
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
Acronym
FOENIX-CCA4
Official Title
Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement
Keywords
Futibatinib, Advanced cholangiocarcinoma, cholangiocarcinoma, FGFR2, Fusion, Rearrangemen, TAS-120

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm A
Arm Type
Experimental
Arm Description
TAS-120 (20mg) tablets, oral; 21-day cycle
Arm Title
Treatment Arm B
Arm Type
Experimental
Arm Description
TAS-120 (16mg) tablets, oral; 21-day cycle
Intervention Type
Drug
Intervention Name(s)
TAS-120
Other Intervention Name(s)
Futibatinib
Intervention Description
TAS-120 is an oral FGFR inhibitor
Primary Outcome Measure Information:
Title
ORR by independent central review
Description
defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on ICR
Time Frame
12 months after the study completion
Secondary Outcome Measure Information:
Title
DoR by independent review
Description
defined as time from the first documentation of response to the first documentation of objective tumor progression by ICR (per RECIST 1.1) or death due to any cause, whichever occurs first
Time Frame
up to 12 months after the study completion
Title
PFS by independent review
Description
defined as the time from date of randomization to the date of documentation of disease progression by ICR per RECIST (version 1.1, 2009) or date of death, whichever comes first
Time Frame
up to 12 months after the study completion
Title
ORR per Investigator assessment
Description
defined as proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST v1.1).
Time Frame
up to 12 months after the study completion
Title
DoR per Investigator assessment
Description
defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first
Time Frame
up to 12 months after the study completion
Title
PFS per Investigator assessment
Description
defined as the time from date of randomization to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first
Time Frame
up to 12 months after the study completion
Title
OS
Description
defined as the time from the date of randomization until the date of death due to any cause.
Time Frame
up to 12 months after the study completion
Title
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Description
Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0. including serious adverse events (SAEs) and dose modifications.
Time Frame
up to 12 months after the study completion
Title
Change from Baseline in Quality of life as assessed by EORTC QLQ-C30
Description
Change from Baseline in quality of life as assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Time Frame
up to 12 months after the study completion
Title
Change from Baseline in Quality of life as assessed by EuroQol-5D (EQ-5D )
Description
Change from Baseline in Quality of Life as Assessed by European Quality of Life - 5 Dimensions-3 Levels (EQ-5D-3L) Scale Score.
Time Frame
up to 12 months after the study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: History or current evidence of calcium and phosphate homeostasis disorder Current evidence of clinically significant retinal disorder Treatment with any of the following within the specified time frame prior to the first dose of futibatinib: 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 Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks 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 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. Patients with prior FGFR-directed therapy A serious illness or medical condition(s) including (but not limited to) the following: Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month Known acute systemic infection 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 Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib. 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. 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. Pregnant or lactating female. Known hypersensitivity or severe reaction to futibatinib or its excipients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taiho Oncology, INC
Phone
609-250-7336
Email
clinicaltrialinfo@taihooncology.com
Facility Information:
Facility Name
University of California San Diego UCSD - Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
sdad@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Burgoyne Adam
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
888-734-5322
Email
pphilip1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Philip Philip
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
ngabrailmd@aol.com
First Name & Middle Initial & Last Name & Degree
Nashat Gabrail
Facility Name
Texas Oncology
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606-5208
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
325-692-0188
Email
anton.melnyk@usoncology.com
First Name & Middle Initial & Last Name & Degree
Camacho Luis
Facility Name
The Liver Institute at Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
PriyankaAcharya@mhd.com
First Name & Middle Initial & Last Name & Degree
Parvez Mantry
Facility Name
Center for Oncology and Blood Disorders
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
jojo@clinvax.com
First Name & Middle Initial & Last Name & Degree
Camacho Luis
Facility Name
CEMIC
City
Caba
ZIP/Postal Code
1431
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+54 5299-0100
Email
julieta.grasselli@gmail.com
First Name & Middle Initial & Last Name & Degree
Julieta Grasselli
Facility Name
Hospital Britanico
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
AEB1280
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+54 4309-6400
Email
lubq1@yahoo.com.ar
First Name & Middle Initial & Last Name & Degree
Luciana Bella Quero
Facility Name
Sanatorio de la Mujer
City
Rosario
ZIP/Postal Code
S2013
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+54 640-5260
Email
cristina_nasurdi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Cristina Nasurdi
Facility Name
Instituto do Cancer do Estado de Sao Paulo
City
Cerqueira César
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+55 11 9 9644-6112
Email
marlene.salgado@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Camila Motta Venchiarutti Moniz
Facility Name
IOP - Instituto de Oncologia do Parana
City
Curitiba
ZIP/Postal Code
80530-010
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+55 3207-9788
Email
mariana.brandao@iop.com.br
First Name & Middle Initial & Last Name & Degree
Luciano Semensato Biela
Facility Name
Hospital Erasto Gaertner
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+55 3361-5195
Email
andressaschuta@gmail.com
First Name & Middle Initial & Last Name & Degree
Andressa Ribas
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
São José Do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+ 55 3201-5054
Email
caldeira.kamylla@gmail.com
First Name & Middle Initial & Last Name & Degree
Kathia Cristina Abadalla
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200123
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
13661222111
Email
lijin@csco.org.cn
First Name & Middle Initial & Last Name & Degree
Jin Li
Facility Name
Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+39 214 3838
Email
giovanni.brandi@unibo.it
First Name & Middle Initial & Last Name & Degree
Giovanni Brandi
Facility Name
IRCCS Humanitas Research Hospital
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
39 822 44573
Email
lorenza.rimassa@hunimed.eu
First Name & Middle Initial & Last Name & Degree
Lorenza Rimassa
Facility Name
AOUI Verona - Ospedale Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+39 812 8148
Email
davide.melisi@gmail.com
First Name & Middle Initial & Last Name & Degree
Davide Melisi
Facility Name
National Cancer Center Hospital East
City
Kashiwa-Shi
ZIP/Postal Code
277-0882
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81958197200
Email
kazuowat@east.ncc.go.jp
First Name & Middle Initial & Last Name & Degree
Susumu Watanabe
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susumu Eguchi
Phone
81-958197200
Email
Sueguchi@nagasaki-uc.ac.jp
First Name & Middle Initial & Last Name & Degree
Susumu Eguchi
Facility Name
Nagoya University Hospital
City
Nagoya-shi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81-741-2111
Email
tmzn@med.nagoya-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Takashi Mizuno
Facility Name
Osaka Metropolitan University Hospital
City
Osaka-Fu
ZIP/Postal Code
558-8585
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+81-(0)6-6605-3558
Email
m1297198@msic.med.osaka-cu.ac.jp
First Name & Middle Initial & Last Name & Degree
Hiroji Shinkawa
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
82 10-9346-2846
Email
onelement@daum.net
First Name & Middle Initial & Last Name & Degree
Il Hwan Kim
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82 825124028
Email
drosy@dau.ac.kr
First Name & Middle Initial & Last Name & Degree
Sung Yong Oh
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82 200-5519
Email
wytak@knu.ac.kr
First Name & Middle Initial & Last Name & Degree
Won Young Tak
Facility Name
Gyeongsang National University Hospital
City
Jinju
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82 750 8063
Email
newatp@naver.com
First Name & Middle Initial & Last Name & Degree
Jung Hun Kang
Facility Name
CHA Bundang Medical Center
City
Seongnam
ZIP/Postal Code
13532
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
810 8556-7223
Email
hongjaechon@gmail.com
First Name & Middle Initial & Last Name & Degree
Hongjae Chon
Facility Name
Yonsei University Health System - Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
82 10-2698-3874
Email
choihj@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Hye Jin Choi
Facility Name
The Catholic University of Korea, St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
82 22586044
Email
angelamd@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Myung Ah Lee
Facility Name
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+48 34 88 930
Email
mariusz.kwiatkowski@swk.med.pl
First Name & Middle Initial & Last Name & Degree
Piotr Wysocki
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
City
Lublin
ZIP/Postal Code
20-0920
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+48 600 238 474
Email
achrzanowska@cozl.eu
First Name & Middle Initial & Last Name & Degree
Agata Chrzanowska-Kapica
Facility Name
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+48 227 103 035
Email
marta.jackiewicz-papierowska@ecz-otwock.pl
First Name & Middle Initial & Last Name & Degree
Cezary Szcylik
Facility Name
Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+48 5061592
Email
lwyrwicz@coi.pl
First Name & Middle Initial & Last Name & Degree
Lucjan Wyrwicz
Facility Name
Fundação Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+351 21 048 0200
Email
nuno.couto@fundacaochampalimaud.pt
First Name & Middle Initial & Last Name & Degree
Nuno Couto
Facility Name
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+351 21 780 5257
Email
carla.i.matos@chln.min-saude.pt
First Name & Middle Initial & Last Name & Degree
Catarina Abreu
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
34-914-269394
Email
tmacarulla@gmail.com
First Name & Middle Initial & Last Name & Degree
Teresa Macarulla Mercadé
Facility Name
Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
34-260
Email
blaquente@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Berta Laquente Saez
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
34-26-9394
Email
fgalindo.hgugm@hotmail.com
First Name & Middle Initial & Last Name & Degree
Andres J. Munoz Martin
Facility Name
Hospital Universitario 12 de octubre
City
Madrid
ZIP/Postal Code
28043
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
34-908-926
Email
drcofi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jorge Adeva Alfonso
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
34-255 400
Email
eecc@unav.es
First Name & Middle Initial & Last Name & Degree
Mariano Ponz-Sarvise
Facility Name
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
7-7317123
Email
chiutaijan@gmail.com
First Name & Middle Initial & Last Name & Degree
Tai-Jan Chiu
Facility Name
Taichung Veterans General Hospital
City
Taichang
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
886-23592525
Email
yansh@vghtc.gov.tw
First Name & Middle Initial & Last Name & Degree
Sheng-shun Yang
Facility Name
Kaohsiung Medical University Hospital
City
Tainan
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
886-312-1101
Email
leochen@nhri.org.tw
First Name & Middle Initial & Last Name & Degree
Li-Tzong Chen
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
886-23123456
Email
chihhunghsu@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chih-Hung hSU
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
886 2875-7270
Email
mhchen9@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Ming-Huang Chen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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