Access to Ivosidenib for Patients with Advanced Cholangiocarcinoma
An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
PHASE3 · Servier · NCT05876754
This study is testing if a daily pill called ivosidenib can help adults with advanced bile duct cancer feel better and live longer after their previous treatments.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Servier (industry) |
| Drugs / interventions | radiation |
| Locations | 84 sites (Yerevan and 83 other locations) |
| Trial ID | NCT05876754 on ClinicalTrials.gov |
What this trial studies
This Phase 3b study evaluates the safety and effectiveness of ivosidenib in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma. Participants will take 500 mg of ivosidenib orally once daily for 28-day cycles, with treatment continuing as long as clinical benefit is observed. The study includes a minimum of six visits over 18 months to monitor health outcomes and quality of life. It aims to gather additional data on the drug's impact in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults with nonresectable or metastatic cholangiocarcinoma who have specific gene mutations and have previously undergone systemic therapy.
Not a fit: Patients who have received prior IDH1 inhibitors or those with recent systemic cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced cholangiocarcinoma.
How similar studies have performed: Other studies have shown positive outcomes with similar treatments, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yerevan and 83 other locations
- Erebouni MC — Yerevan, Armenia (COMPLETED)
- National Center of Oncology of Ra M — Yerevan, Armenia (COMPLETED)
- Royal brisbane & Women's Hospital — Brisbane, Australia (COMPLETED)
- St Vincent's Hospital — Fitzroy, Australia (COMPLETED)
- St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC) — Subiaco, Australia (COMPLETED)
- Kinghorn Cancer Centre — Sydney, Australia (COMPLETED)
- The Queen Elizabeth Hospital — Woodville, Australia (COMPLETED)
- Medizinische Universitaet Graz — Graz, Austria (COMPLETED)
- Ordensklinikum Linz GmbH — Linz, Austria (COMPLETED)
- Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum — Salzburg, Austria (COMPLETED)
- Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I — Vienna, Austria (COMPLETED)
- Universite Libre de Bruxelles ULB - — Brussels, Belgium (COMPLETED)
- Universitair Ziekenhuis Gent UZ Gent — Ghent, Belgium (COMPLETED)
- UZ Leuven — Leuven, Belgium (COMPLETED)
- Cliniques Univ St Luc - Gastro-Enterology — Woluwe-Saint-Lambert, Belgium (COMPLETED)
- Tom Baker Cancer Center — Calgary, Canada (COMPLETED)
- NSHA, QEII Health Sciences Centre — Halifax, Canada (COMPLETED)
- London Regional Cancer Program — London, Canada (COMPLETED)
- Princess Margaret Cancer Center — Toronto, Canada (COMPLETED)
- Sunnybrook Health Sciences Centre — Toronto, Canada (COMPLETED)
- Hôpital Privé Jean Mermoz — Lyon, France (COMPLETED)
- Hopital de la Timone — Marseille, France (COMPLETED)
- CHU Montpellier — Montpellier, France (COMPLETED)
- Centre Hospitalier Universitaire de Nantes CHU de Nantes — Nantes, France (COMPLETED)
- Institute Mutualiste Montsouris — Paris, France (COMPLETED)
- CHU Bordeaux, Hôpital Haut-Lévêque — Pessac, France (COMPLETED)
- CHU de Poitiers — Poitiers, France (COMPLETED)
- Charite Universittsmedizin Berlin — Berlin, Germany (COMPLETED)
- Universitaetsklinikum Carl-Gustav-Carus — Dresden, Germany (COMPLETED)
- Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf — Düsseldorf, Germany (COMPLETED)
- Universitaetsklinikum Frankfurt — Frankfurt, Germany (COMPLETED)
- Medizinische Fakultaet der Universitaet Freiburg — Freiburg im Breisgau, Germany (COMPLETED)
- Medizinische Hochschule Hannover — Hanover, Germany (COMPLETED)
- Klinikum der Universitaet Muenchen-Grosshadern — München, Germany (COMPLETED)
- Cork University Hospital — Cork, Ireland (COMPLETED)
- St. James Hospital — Dublin, Ireland (COMPLETED)
- St. Vincent's Private Hospital — Dublin, Ireland (COMPLETED)
- Policlinico S. Orsola-Malpighi — Bologna, Italy (COMPLETED)
- AOU Careggi — Florence, Italy (COMPLETED)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (COMPLETED)
- Ospedale San Raffaele — Milan, Italy (COMPLETED)
- Istituto Nazionale Tumori IRCCS Fondazione Pascale — Naples, Italy (COMPLETED)
- IRCCS Arcispedale Santa Maria Nuova — Reggio Emilia, Italy (COMPLETED)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (COMPLETED)
- Humanitas Research Hospital — Rozzano, Italy (COMPLETED)
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS) — San Giovanni Rotondo, Italy (COMPLETED)
- A.O.U. Città della Salute e della Scienza di Torino — Turin, Italy (COMPLETED)
- AOUI Verona - Ospedale Borgo Roma — Verona, Italy (COMPLETED)
- Kanagawa Cancer Center — Kanagawa, Japan (RECRUITING)
- Kumamoto University hospital — Kumamoto, Japan (RECRUITING)
+34 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Institut de Recherches Internationales Servier, Clinical Studies Department
- Email: scientificinformation@servier.com
- Phone: +33 1 55 72 60 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cholangiocarcinoma, CCA, Pretreated locally advanced or metastatic cholangiocarcinoma