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

Status: Recruiting
Location: See all (78) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Armenia
Erebouni MC
COMPLETED
Yerevan
National Center of Oncology of Ra M
COMPLETED
Yerevan
Australia
Royal brisbane & Women's Hospital
COMPLETED
Brisbane
St Vincent's Hospital
COMPLETED
Fitzroy
St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
COMPLETED
Subiaco
Kinghorn Cancer Centre
COMPLETED
Sydney
The Queen Elizabeth Hospital
COMPLETED
Woodville
Austria
Medizinische Universitaet Graz
COMPLETED
Graz
Ordensklinikum Linz GmbH
COMPLETED
Linz
Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum
COMPLETED
Salzburg
Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I
COMPLETED
Vienna
Belgium
Universite Libre de Bruxelles ULB -
COMPLETED
Brussels
Universitair Ziekenhuis Gent UZ Gent
COMPLETED
Ghent
UZ Leuven
COMPLETED
Leuven
Cliniques Univ St Luc - Gastro-Enterology
COMPLETED
Woluwe-saint-lambert
Canada
Tom Baker Cancer Center
RECRUITING
Calgary
NSHA, QEII Health Sciences Centre
RECRUITING
Halifax
London Regional Cancer Program
RECRUITING
London
Princess Margaret Cancer Center
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
France
Hôpital Privé Jean Mermoz
RECRUITING
Lyon
Hopital de la Timone
RECRUITING
Marseille
CHU Montpellier
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nantes CHU de Nantes
RECRUITING
Nantes
Institute Mutualiste Montsouris
RECRUITING
Paris
CHU Bordeaux, Hôpital Haut-Lévêque
RECRUITING
Pessac
CHU de Poitiers
RECRUITING
Poitiers
Germany
Charite Universittsmedizin Berlin
COMPLETED
Berlin
Universitaetsklinikum Carl-Gustav-Carus
COMPLETED
Dresden
Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf
COMPLETED
Düsseldorf
Universitaetsklinikum Frankfurt
COMPLETED
Frankfurt
Medizinische Fakultaet der Universitaet Freiburg
COMPLETED
Freiburg Im Breisgau
Medizinische Hochschule Hannover
COMPLETED
Hanover
Klinikum der Universitaet Muenchen-Grosshadern
COMPLETED
München
Ireland
Cork University Hospital
COMPLETED
Cork
St. James Hospital
COMPLETED
Dublin
St. Vincent's Private Hospital
COMPLETED
Dublin
Italy
Policlinico S. Orsola-Malpighi
COMPLETED
Bologna
AOU Careggi
COMPLETED
Florence
Fondazione IRCCS Istituto Nazionale dei Tumori
COMPLETED
Milan
Ospedale San Raffaele
COMPLETED
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale
COMPLETED
Napoli
IRCCS Arcispedale Santa Maria Nuova
COMPLETED
Reggio Emilia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
COMPLETED
Roma
Humanitas Research Hospital
COMPLETED
Rozzano
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
COMPLETED
San Giovanni Rotondo
A.O.U. Città della Salute e della Scienza di Torino
COMPLETED
Turin
AOUI Verona - Ospedale Borgo Roma
COMPLETED
Verona
Netherlands
Amsterdam UMC, location AMC
COMPLETED
Amsterdam
Universiteit Maastricht UM - Maastricht University Medical Centre MUMC
COMPLETED
Limburg
Republic of Korea
CHA Bundang Medical Center
COMPLETED
Seongnam
Asan Medical Center
COMPLETED
Seoul
Samsung Medical Center
COMPLETED
Seoul
Seoul National University
COMPLETED
Seoul
Yonsei University Health System
COMPLETED
Seoul
Romania
Institutul Clinic Fundeni
RECRUITING
Bucharest
Regional Institute of Gastroenterology and Hepatology
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfantu Necta
RECRUITING
Craiova
Radiotherapy Center Cluj
RECRUITING
Otopeni
Municipal Hospital Ploiesti
RECRUITING
Ploieşti
Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
COMPLETED
A Coruña
Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)
COMPLETED
Barcelona
Hospital Universitario Reina Sofa
COMPLETED
Córdoba
Hospital General de Elche
COMPLETED
Elche
Hospital General Universitario Gregorio Maranon
COMPLETED
Madrid
Hospital Universitario 12 de octubre
COMPLETED
Madrid
Hospital Universitario Fundacion Jimenez Diaz
COMPLETED
Madrid
Hospital Universitario HM Sanchinarro
COMPLETED
Madrid
Hospital Universitario de Navarra
COMPLETED
Pamplona
Hospital Universitario Marqués de Valdecilla
COMPLETED
Santander
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Karolinska University Hospital
RECRUITING
Stockholm
United Kingdom
University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)
COMPLETED
Birmingham
The Beatson Institute West of Scotland Cancer Research
COMPLETED
Glasgow
Imperial College London
COMPLETED
London
University College London Hospital NHS Trust
COMPLETED
London
The Christie NHS Foundation Trust
COMPLETED
Manchester
The Newcastle Upon Tyne Hospitals
COMPLETED
Newcastle Upon Tyne
Contact Information
Primary
Institut de Recherches Internationales Servier, Clinical Studies Department
scientificinformation@servier.com
+33 1 55 72 60 00
Time Frame
Start Date: 2023-05-03
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 220
Treatments
Experimental: Ivosidenib
Ivosidenib 500 mg, taken orally as two 250 mg tablets once daily for an unlimited amount of continuous 28-day cycles
Related Therapeutic Areas
Cholangiocarcinoma (Bile Duct Cancer)
Sponsors
Leads: Servier Affaires Médicales

This content was sourced from clinicaltrials.gov

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