Trial Title:
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
NCT ID:
NCT05948475
Condition:
Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Conditions: Keywords:
Refractory/Relapsed Cholangiocarcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tinengotinib 8 mg
Description:
Subjects randomized to receive tinengotinib will receive a starting dose of either 8 mg
QD., self-administered orally QD in 28-day cycles.
Arm group label:
Tinengotinib 8 mg QD
Intervention type:
Drug
Intervention name:
Tinengotinib 10 mg
Description:
Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg
QD., self-administered orally QD in 28-day cycles.
Arm group label:
Tinengotinib 10 mg QD
Intervention type:
Drug
Intervention name:
Physician's Choice
Description:
For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two
weeks, with two administrations per each 28-day cycle.
Arm group label:
Physician's Choice
Summary:
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate
the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with
Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR
Inhibitor-Refractory/Relapsed Cholangiocarcinoma
Detailed description:
Approximately 200 subjects will be enrolled. Eligible subjects will be randomized in a
2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice
in Part A; and eligible subjects will be randomized in a 2:1 ratio to receive the
recommended Part B dose or selected dose or Physician's Choice in Part B.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ≥ 18 years of age at the time of signing the informed consent form (ICF).
2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with
radiological evidence of unresectable or metastatic disease.
3. Documentation of FGFR2 fusion/rearrangement gene status
4. Subjects must have received at least one line of prior chemotherapy and exactly one
FDA approved FGFR inhibitor.
Exclusion Criteria:
1. Prior receipt of two or more FGFR inhibitors, either approved or investigational
drugs.
2. Subjects with known brain or central nervous system (CNS) metastases that have
radiologically or clinically progressed in the 28 days prior to initiation of
therapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNS
metastases that have been clinically stable for 14 days on steroids without
escalation of steroids are eligible for enrollment.
3. Subjects with a known concurrent malignancy that is progressing or requires active
treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of
the cervix, or other noninvasive or indolent malignancy, including those that have
previously undergone potentially curative therapy.
4. Subjects who have received prior systemic therapy or investigational study drug ≤ 5
half-lives or 14 days, whichever is shorter, prior to starting the study drug or who
have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2
alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs)
of prior therapy.
5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone
therapy may be allowed with Sponsor approval.
6. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field
radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not
recovered from AEs of prior therapy.
7. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg
systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with
antihypertensive medications at screening)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA Medical Center
Address:
City:
Santa Monica
Zip:
90401
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Saeed Sadeghi
Email:
Principal Investigator
Facility:
Name:
Stanford Cancer Center
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swetha Vadde
Phone:
650-721-3343
Email:
svadde@stanford.edu
Investigator:
Last name:
Lipika Goyal
Email:
Principal Investigator
Facility:
Name:
The University of Kansas Cancer Center
Address:
City:
Westwood
Zip:
90024
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Vallandingham
Phone:
913-588-0593
Email:
avallandingham@kumc.edu
Investigator:
Last name:
Raed M Al-Rajabi
Email:
Principal Investigator
Facility:
Name:
Mount Sinai Comprehensive Cancer Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ana Lacombe
Phone:
305-674-2625
Phone ext:
53758
Email:
Ana.lacombe@msmc.com
Investigator:
Last name:
Mike Cusnir
Email:
Principal Investigator
Facility:
Name:
The University of Chicago Hospitals
Address:
City:
Chicago
Zip:
60601
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Chih-Yi Liao
Email:
Principal Investigator
Facility:
Name:
UMass Memorial Medical Center
Address:
City:
Worcester
Zip:
01655
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Martin Alexander
Email:
Principal Investigator
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48103
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Vaibhav Sahai
Email:
Principal Investigator
Facility:
Name:
Henry Ford
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Maria Diab
Email:
Principal Investigator
Facility:
Name:
University of Minnesota- Masonic Cancer Center, M Health Fairview
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Greeno Edward
Email:
Principal Investigator
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jenna Blamowski
Email:
Jenna.blamowski@roswellpark.org
Contact backup:
Last name:
Sarah Chatley
Phone:
716-845-4846
Email:
Sarah.chatley@roswellpark.org
Investigator:
Last name:
Christos Fountzilas
Email:
Principal Investigator
Facility:
Name:
Messino Cancer Centers
Address:
City:
Asheville
Zip:
28806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Josh Duckett
Phone:
828-212-7021
Email:
Josh.duckett@aoncology.com
Investigator:
Last name:
Andrew Beardsley
Email:
Principal Investigator
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Peggy Fowler
Email:
peggy.fowler@Uhhospitals.org
Investigator:
Last name:
Amit Mahipal
Email:
Principal Investigator
Facility:
Name:
Tennessee Oncology- Nashville
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emma Brennan
Phone:
615-917-9153
Email:
Emma.brennan@scri.com
Investigator:
Last name:
Meredith S Pelster
Email:
Principal Investigator
Facility:
Name:
Vanderbilt-Ingram Cancer Center
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Thatcher Heumann
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75201
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
David Hsieh
Email:
Principal Investigator
Facility:
Name:
Texas Oncology-Sammons Cancer Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Kitchens Benjamin
Email:
Principal Investigator
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77002
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Milind M Javle
Email:
Principal Investigator
Facility:
Name:
University of Virginia Cancer Center
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristen Harris
Phone:
434-297-5724
Email:
KAH2GV@uvahealth.org
Investigator:
Last name:
Kunk Paul
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53202
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Alexandria T Phan
Email:
Principal Investigator
Facility:
Name:
Ordensklinikum Linz GmbH
Address:
City:
Linz
Country:
Austria
Status:
Recruiting
Investigator:
Last name:
Bernhard Doleschal
Email:
Principal Investigator
Facility:
Name:
Landesklinikum Wiener Neustadt
Address:
City:
Wiener Neustadt
Country:
Austria
Status:
Not yet recruiting
Investigator:
Last name:
Birgit Gruenberger
Email:
Principal Investigator
Facility:
Name:
Universitair Ziekenhuis Antwerpen
Address:
City:
Antwerp
Country:
Belgium
Status:
Not yet recruiting
Investigator:
Last name:
TimonV andamme
Email:
Principal Investigator
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Gent
Country:
Belgium
Status:
Not yet recruiting
Investigator:
Last name:
Karen P Geboes
Email:
Principal Investigator
Facility:
Name:
Universitair Ziekenhuis Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Not yet recruiting
Investigator:
Last name:
Jeroen Dekervel
Email:
Principal Investigator
Facility:
Name:
Institut Sainte Catherine - Institut du Cancer Avignon Provence
Address:
City:
Avignon
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Laurent Mineur
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Régional Universitaire de Besançon
Address:
City:
Besancon
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Angelique Vienot
Email:
Principal Investigator
Facility:
Name:
Hopital Beaujon
Address:
City:
Clichy
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Mohamed Bouattour
Email:
Principal Investigator
Facility:
Name:
Hopital Franco-Britannique - Fondation Cognacq-Jay
Address:
City:
Levallois-Perret
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Benoist Chibaudel
Email:
Principal Investigator
Facility:
Name:
Clinique de la Sauvegarde
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Yann Molin
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Universitaire de Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Eric Assenat
Email:
Principal Investigator
Facility:
Name:
Hopital Saint Antoine
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Violaine Ozenne
Email:
Principal Investigator
Facility:
Name:
Institut de Cancerologie Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Antoine Hollebecque
Email:
Principal Investigator
Facility:
Name:
Krebszentrum Reutlingen
Address:
City:
Baden
Country:
Germany
Status:
Recruiting
Investigator:
Last name:
Stefan Kubicka
Email:
Principal Investigator
Facility:
Name:
Krankenhaus Nordwest gGmbH
Address:
City:
Frankfurt
Country:
Germany
Status:
Recruiting
Investigator:
Last name:
Thorsten O Goetze
Email:
Principal Investigator
Facility:
Name:
Asklepios Klinik Altona
Address:
City:
Hamburg
Country:
Germany
Status:
Not yet recruiting
Investigator:
Last name:
Dirk Arnold
Email:
Principal Investigator
Facility:
Name:
Medizinische Hochschule Hannover
Address:
City:
Hannover
Country:
Germany
Status:
Not yet recruiting
Investigator:
Last name:
Vogel Saborowski
Email:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)
Address:
City:
Heidelberg
Country:
Germany
Status:
Recruiting
Investigator:
Last name:
Christoph Springfeld
Email:
Principal Investigator
Facility:
Name:
Ludwig-Maximilians-Universität München Kum
Address:
City:
München
Country:
Germany
Status:
Not yet recruiting
Investigator:
Last name:
Volker Heinemann
Email:
Principal Investigator
Facility:
Name:
Clinica Oncologica, Ospedali Riuniti Umberto 1
Address:
City:
Ancona
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Rossana Berardi
Email:
Principal Investigator
Facility:
Name:
Candiolo Cancer Institute - FPO IRCCS
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Elisabetta Fenocchio
Email:
Principal Investigator
Facility:
Name:
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Address:
City:
Meldola
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Ilario Giovanni Rapposelli
Email:
Principal Investigator
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguard
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Salvatore Siena
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Monica Niger
Email:
Principal Investigator
Facility:
Name:
Istituto Europeo di Oncologia IRCCS
Address:
City:
Milan
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Nicola Fazio
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Address:
City:
Napoli
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Erika Martinelli
Email:
Principal Investigator
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Antonio Avallone
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria di Parma
Address:
City:
Parma
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Ingrid Garajova
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero-Universitaria Pisana
Address:
City:
Pisa
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Gianluca Masi
Email:
Principal Investigator
Facility:
Name:
Humanitas Research Hospital
Address:
City:
Rozzano
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Lorenza Rimassa
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Address:
City:
Siena
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Michele Maio
Email:
Principal Investigator
Facility:
Name:
AOUI Verona - Ospedale Borgo Roma
Address:
City:
Verona
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Davide Melisi
Email:
Principal Investigator
Facility:
Name:
CHA Bundang Medical Center
Address:
City:
Seongnam-si
Zip:
13496
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seonyoung Park
Phone:
82-31-780-3440
Email:
seonyoung7973@gmail.com
Contact backup:
Last name:
Eun Jin Kim
Phone:
82-10-6755-0814
Email:
Happy767807@gmail.com
Investigator:
Last name:
Hongjae Chon
Email:
Principal Investigator
Investigator:
Last name:
Beodeul Kang
Email:
Sub-Investigator
Investigator:
Last name:
Jung Sun Kim
Email:
Sub-Investigator
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju-si
Zip:
52727
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hye-Kyoung Lee
Phone:
82-55-750-9454
Email:
heyd@naver.com
Investigator:
Last name:
Jung Hun Kang
Email:
Principal Investigator
Investigator:
Last name:
Seong Je Kim
Email:
Sub-Investigator
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Hwasun
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Su Jin Lee
Phone:
82-61-379-8872
Email:
sj720100@naver.com
Contact backup:
Last name:
Jeong Ah Im
Phone:
82-61-379-7700
Email:
wjddkdla@naver.com
Investigator:
Last name:
Jun Eul Hwang
Email:
Principal Investigator
Investigator:
Last name:
Woo Kyun Bae
Email:
Sub-Investigator
Investigator:
Last name:
Hyun Jin Bang
Email:
Sub-Investigator
Facility:
Name:
Inje University Haeundae Paik Hospital
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Eunyeong Park
Phone:
82-51-797-0096
Email:
eyey8411@naver.com
Contact backup:
Last name:
Subin Lee
Phone:
82-51-797-0097
Email:
onck2@wabetree.com
Investigator:
Last name:
Il Hwan Kim
Email:
Principal Investigator
Investigator:
Last name:
Myoung Joo Kang
Email:
Sub-Investigator
Investigator:
Last name:
Yong June Lee
Email:
Sub-Investigator
Facility:
Name:
Dong-A University Hospital
Address:
City:
Busan
Zip:
49201
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Minseong Seon
Investigator:
Last name:
Sung Yong Oh
Email:
Principal Investigator
Investigator:
Last name:
Suee Lee
Email:
Sub-Investigator
Investigator:
Last name:
Seok Jae Huh
Email:
Sub-Investigator
Investigator:
Last name:
Hye Ryeon Kim
Email:
Sub-Investigator
Facility:
Name:
Kyungpook National University Hospital
Address:
City:
Daegu
Zip:
41944
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sun hee Lee
Phone:
82 53-200-5515
Email:
shlie370@naver.com
Investigator:
Last name:
Won young Tak
Email:
Principal Investigator
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jinseon Kim
Phone:
82-32-460-3227
Email:
gilonco2262@naver.com
Contact backup:
Last name:
So Hee Choi
Phone:
82-10-9271-7739
Email:
hihi7739@naver.com
Investigator:
Last name:
Sun-jin Sym
Email:
Principal Investigator
Investigator:
Last name:
Jihong Bae
Email:
Sub-Investigator
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Hyeonju Jung
Phone:
82-2-2072-7611
Email:
hyunju7766@snu.ac.kr
Contact backup:
Last name:
Mie soon In
Phone:
82-2 2072-0795
Email:
inmisoon@snu.ac.kr
Investigator:
Last name:
Do-Youn Oh
Email:
Principal Investigator
Facility:
Name:
Yonsei University Health System - Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
somang Kim
Phone:
82-10-6701-3112
Email:
DMONCO44@yuhs.ac
Investigator:
Last name:
Hye Jin Choi
Email:
Principal Investigator
Investigator:
Last name:
Chang Gon Kim
Email:
Sub-Investigator
Investigator:
Last name:
Choong-kun Lee
Email:
Sub-Investigator
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
EunKyung Park
Email:
ekek.park@samsung.com
Investigator:
Last name:
Joon Oh Park
Email:
Principal Investigator
Investigator:
Last name:
Young Suk Park
Email:
Sub-Investigator
Investigator:
Last name:
Seung Tae Kim
Email:
Sub-Investigator
Investigator:
Last name:
Jung Yong Hong
Email:
Sub-Investigator
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Soohyun Park
Phone:
82-10-8686-4176
Email:
soohyuning99@gmail.com
Contact backup:
Last name:
Noeul Kim
Phone:
82-2-2626-2212
Email:
zrlashdmfz@naver.com
Investigator:
Last name:
Sang Cheul Oh
Email:
Principal Investigator
Investigator:
Last name:
Yoon Namgung
Email:
Sub-Investigator
Investigator:
Last name:
Woojin Kim
Email:
Sub-Investigator
Facility:
Name:
Amsterdam UMC, location AMC
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Status:
Not yet recruiting
Investigator:
Last name:
Johanna Wilmink
Email:
Principal Investigator
Facility:
Name:
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
Address:
City:
Warszawa
Country:
Poland
Status:
Not yet recruiting
Investigator:
Last name:
Lucjan S Wyrwicz,
Email:
Principal Investigator
Facility:
Name:
Fundação Champalimaud
Address:
City:
Lisboa
Country:
Portugal
Status:
Not yet recruiting
Investigator:
Last name:
Nuno Couto
Email:
Principal Investigator
Facility:
Name:
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
Address:
City:
Lisbon
Country:
Portugal
Status:
Not yet recruiting
Investigator:
Last name:
Catarina Abreu
Email:
Principal Investigator
Facility:
Name:
Hospital Clínic de Barcelona
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Alejandro Forner Gonzalez
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d´Hebron
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Macarulla Mercade Teresa
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Reina Sofa
Address:
City:
Cordoba
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Rosa Maria Rodriguez Alonso,
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Mariano Ponz
Email:
Principal Investigator
Facility:
Name:
HM Hospital Universitario Madrid Sanchinarro - CIOCC
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Rafael Alvarez Gallego
Email:
Principal Investigator
Facility:
Name:
Hospital General Universitario Gregorio Maranon
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Andres J Munoz Martin
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario 12 de octubre
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Jorge Adeva Alfonso
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Angela Lamarca
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Ramón y Cajal
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Carmen Guillen Ponce
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Mariano Ponz
Email:
Principal Investigator
Facility:
Name:
Hospital Clinico Universitario de Santiago de Compostela
Address:
City:
Santiago De Compostela
Country:
Spain
Status:
Not yet recruiting
Investigator:
Last name:
Sonia Candamio
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Miguel Servet
Address:
City:
Zaragoza
Country:
Spain
Status:
Not yet recruiting
Investigator:
Last name:
Roberto Antonio Pazo Cid
Email:
Principal Investigator
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Cherie Chen
Phone:
886-903-206-006
Email:
cheriechen@nhri.edu.tw
Contact backup:
Last name:
Yu-Chi Chang
Phone:
886- 7-3121101
Phone ext:
5610
Email:
yuchichang303@nhri.edu.tw
Investigator:
Last name:
Li-Tzong Chen
Email:
Principal Investigator
Facility:
Name:
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Address:
City:
Kaohsiung
Zip:
833401
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chen-Yi Lin
Phone:
886 7 7317 123
Phone ext:
3679
Email:
aa036533@gmail.com
Investigator:
Last name:
Tai-Jan Chiu
Email:
Principal Investigator
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Chieh-Ling (Iris) Yen
Phone:
886-4-23592525
Phone ext:
82593
Email:
c9626@yahoo.com.tw
Investigator:
Last name:
Teng-Yu Lee
Email:
Principal Investigator
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Tz-Min Chao
Phone:
886-2-2312-3456
Phone ext:
67857
Email:
tzminchao@ntuh.gov.tw
Investigator:
Last name:
Chih-Hung Hsu
Email:
Principal Investigator
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Shu-Hui Chou
Phone:
886-228712121
Phone ext:
2935
Email:
anitachou3173@gmail.com
Contact backup:
Last name:
Joanne Song
Phone:
886-228712121
Phone ext:
2935
Email:
shuwei0425@gmail.com
Investigator:
Last name:
Ming-Huang Chen
Email:
Principal Investigator
Facility:
Name:
Royal Marsden Hospital NHS
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Cunningham David
Email:
Principal Investigator
Facility:
Name:
UCG-1st floor central
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Bridgewater John A
Email:
Principal Investigator
Facility:
Name:
The Christie NHS Foundation Trust - Christie Hospital
Address:
City:
Manchester
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
McNamara Mairead
Email:
Principal Investigator
Facility:
Name:
Nottingham University Hospitals NHS Trust
Address:
City:
Nottingham
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Arora Arvind
Email:
Principal Investigator
Start date:
December 20, 2023
Completion date:
August 2026
Lead sponsor:
Agency:
TransThera Sciences (Nanjing), Inc.
Agency class:
Industry
Source:
TransThera Sciences (Nanjing), Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05948475
