RecruitingPhase 3NCT05876754

An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Sponsor

Servier Affaires Médicales

Enrollment

220 participants

Start Date

May 3, 2023

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early access study gives patients with advanced bile duct cancer (cholangiocarcinoma) access to a targeted drug called ivosidenib, which works against a specific gene mutation called IDH1. This study is for patients whose cancer has already been treated with at least one prior therapy. **You may be eligible if...** - You have advanced or metastatic bile duct cancer that cannot be surgically removed or cured - Your tumor has been tested and carries an IDH1 R132 mutation - You have received at least one prior treatment for your bile duct cancer and recovered from its side effects - You agree to use contraception if pregnancy is a possibility **You may NOT be eligible if...** - You have previously received an IDH1 inhibitor - You have had an organ transplant - You received cancer treatment or radiation within the past 2 weeks - You have active hepatitis B, hepatitis C, or HIV/AIDS - You are pregnant or breastfeeding - You had major surgery within the past 4 weeks - You have brain metastases that require steroid treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvosidenib 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

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NCT05876754

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