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An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Sponsor: Servier Affaires Médicales
Summary
A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.
Official title: An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2023-05-03
Completion Date
2027-12-01
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
Ivosidenib Oral Tablet
Ivosidenib 500 mg
Locations (84)
Erebouni MC
Yerevan, Armenia
National Center of Oncology of Ra M
Yerevan, Armenia
Royal brisbane & Women's Hospital
Brisbane, Australia
St Vincent's Hospital
Fitzroy, Australia
St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
Subiaco, Australia
Kinghorn Cancer Centre
Sydney, Australia
The Queen Elizabeth Hospital
Woodville, Australia
Medizinische Universitaet Graz
Graz, Austria
Ordensklinikum Linz GmbH
Linz, Austria
Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum
Salzburg, Austria
Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I
Vienna, Austria
Universite Libre de Bruxelles ULB -
Brussels, Belgium
Universitair Ziekenhuis Gent UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Cliniques Univ St Luc - Gastro-Enterology
Woluwe-Saint-Lambert, Belgium
Tom Baker Cancer Center
Calgary, Canada
NSHA, QEII Health Sciences Centre
Halifax, Canada
London Regional Cancer Program
London, Canada
Princess Margaret Cancer Center
Toronto, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
Hôpital Privé Jean Mermoz
Lyon, France
Hopital de la Timone
Marseille, France
CHU Montpellier
Montpellier, France
Centre Hospitalier Universitaire de Nantes CHU de Nantes
Nantes, France
Institute Mutualiste Montsouris
Paris, France
CHU Bordeaux, Hôpital Haut-Lévêque
Pessac, France
CHU de Poitiers
Poitiers, France
Charite Universittsmedizin Berlin
Berlin, Germany
Universitaetsklinikum Carl-Gustav-Carus
Dresden, Germany
Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitaetsklinikum Frankfurt
Frankfurt, Germany
Medizinische Fakultaet der Universitaet Freiburg
Freiburg im Breisgau, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Klinikum der Universitaet Muenchen-Grosshadern
München, Germany
Cork University Hospital
Cork, Ireland
St. James Hospital
Dublin, Ireland
St. Vincent's Private Hospital
Dublin, Ireland
Policlinico S. Orsola-Malpighi
Bologna, Italy
AOU Careggi
Florence, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Italy
IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Humanitas Research Hospital
Rozzano, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
San Giovanni Rotondo, Italy
A.O.U. Città della Salute e della Scienza di Torino
Turin, Italy
AOUI Verona - Ospedale Borgo Roma
Verona, Italy
Kanagawa Cancer Center
Kanagawa, Japan
Kumamoto University hospital
Kumamoto, Japan
Shikoku Cancer Center
Matsuyama, Japan
Osaka International Cancer Institution
Osaka, Japan
Hokkaido University Hospital
Sapporo, Japan
National Cancer Center Hospital
Tokyo, Japan
Amsterdam UMC, location AMC
Amsterdam, Netherlands
Universiteit Maastricht UM - Maastricht University Medical Centre MUMC
Limburg, Netherlands
Institutul Clinic Fundeni
Bucharest, Romania
Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Romania
Centrul de Oncologie Sfantu Necta
Craiova, Romania
Radiotherapy Center Cluj
Otopeni, Romania
Municipal Hospital Ploiesti
Ploieşti, Romania
CHA Bundang Medical Center
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University
Seoul, South Korea
Yonsei University Health System
Seoul, South Korea
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)
Barcelona, Spain
Hospital Universitario Reina Sofa
Córdoba, Spain
Hospital General de Elche
Elche, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario 12 de octubre
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Karolinska University Hospital
Stockholm, Sweden
University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)
Birmingham, United Kingdom
The Beatson Institute West of Scotland Cancer Research
Glasgow, United Kingdom
Imperial College London
London, United Kingdom
University College London Hospital NHS Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
The Newcastle Upon Tyne Hospitals
Newcastle upon Tyne, United Kingdom