An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma (ProvIDHe)
Cholangiocarcinoma
About this trial
This is an interventional treatment trial for Cholangiocarcinoma focused on measuring CCA, Pretreated locally advanced or metastatic cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria: Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects Female patients of childbearing potential must have a negative blood pregnancy test prior to starting treatment and must agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug Male patients with a female partner with childbearing potential must also agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug Exclusion Criteria: Received a prior IDH1 inhibitor Have received a transplant Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1 Have received hepatic radiation, chemoembolization, and radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1 Have ongoing brain metastases requiring steroids Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1 Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness Are pregnant or breastfeeding
Sites / Locations
- Royal brisbane & Women's Hospital
- St Vincent's HospitalRecruiting
- St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
- Kinghorn Cancer Centre
- The Queen Elizabeth HospitalRecruiting
- Medizinische Universitaet Graz
- Ordensklinikum Linz GmbH
- Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum
- Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I
- Universite Libre de Bruxelles ULB -
- Universitair Ziekenhuis Gent UZ Gent
- UZ Leuven
- Cliniques Univ St Luc - Gastro-Enterology
- Hôpital Privé Jean Mermoz
- Hopital de la Timone
- CHU Montpellier
- Centre Hospitalier Universitaire de Nantes CHU de Nantes
- Institute Mutualiste Montsouris
- CHU Bordeaux, Hôpital Haut-Lévêque
- CHU de Poitiers
- Charite Universittsmedizin Berlin
- Universitaetsklinikum Carl-Gustav-Carus
- Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf
- Universitaetsklinikum Frankfurt
- Medizinische Fakultaet der Universitaet Freiburg
- Medizinische Hochschule Hannover
- Klinikum der Universitaet Muenchen-Grosshadern
- Policlinico S. Orsola-Malpighi
- AOU Careggi
- Fondazione IRCCS Istituto Nazionale dei Tumori
- Ospedale San Raffaele
- Istituto Nazionale Tumori IRCCS Fondazione Pascale
- IRCCS Arcispedale Santa Maria Nuova
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Humanitas Research Hospital
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
- A.O.U. Città della Salute e della Scienza di Torino
- AOUI Verona - Ospedale Borgo Roma
- Amsterdam UMC, location AMCRecruiting
- Universiteit Maastricht UM - Maastricht University Medical Centre MUMCRecruiting
- Complejo Hospitalario Universitario A Coruña (CHUAC)
- Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)
- Hospital Universitario Reina Sofa
- Hospital General de Elche
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario 12 de octubre
- Hospital Universitario Fundacion Jimenez Diaz
- Hospital Universitario HM Sanchinarro
- Hospital Universitario de Navarra
- Hospital Universitario Marqués de Valdecilla
- Sahlgrenska University HospitalRecruiting
- Karolinska University Hospital
- University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)
- Imperial College LondonRecruiting
- The Beatson Institute West of Scotland Cancer Research
- University College London Hospital NHS TrustRecruiting
- The Christie NHS Foundation TrustRecruiting
- The Newcastle Upon Tyne Hospitals
Arms of the Study
Arm 1
Experimental
Ivosidenib
Ivosidenib 500 mg, taken orally as two 250 mg tablets once daily for an unlimited amount of continuous 28-day cycles