Trial Title:
An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
NCT ID:
NCT05876754
Condition:
Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Ivosidenib
Conditions: Keywords:
CCA
Pretreated locally advanced or metastatic cholangiocarcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
All patients, care providers, investigators, and outcomes assessors will know that each
patient is taking the active study drug, ivosidenib.
Intervention:
Intervention type:
Drug
Intervention name:
Ivosidenib Oral Tablet
Description:
Ivosidenib 500 mg
Arm group label:
Ivosidenib
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.
Detailed description:
Ivosidenib is approved in the United States and in EU for the treatment of advanced or
metastatic CCA; this study is being conducted to conslidate the data related to the
safety, efficacy, and impact on quality of life for patients. This is an open-label,
single-arm study of ivosidenib, which means that all patients meeting eligibility
criteria will receive two 250 mg ivosidenib tablets, totaling 500mg of drug, to be taken
orally, once daily, for 28 consecutive days, also referred to as one cycle. Additional
cycles can continue as long as clinical benefit is confirmed by an investigator, and
consent is maintained. There will be a screening visit, study visit on day 1 of each
cycle, withdrawal visit within 42 days of stopping treatment, and a follow-up visit every
6 months for up to 18 months after stopping treatment. This results in a minimum of 6
study visits for the completion of one 28-day cycle of ivosidenib. One additional study
visit will be added on day one of each additional cycle of treatment. Study visits will
include an electrocardiogram (ECG), physical exam, tumor assessment, according to local
practive at a given site and blood and urine analyses. If at any point ivosidenib is made
available as a medical prescription at the patient's site, patients will be withdrawn
from the study treatment and patients will be followed to collect data on overall
survival.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Erebouni MC
Address:
City:
Yerevan
Country:
Armenia
Status:
Recruiting
Facility:
Name:
National Center of Oncology of Ra M
Address:
City:
Yerevan
Country:
Armenia
Status:
Recruiting
Facility:
Name:
Royal brisbane & Women's Hospital
Address:
City:
Brisbane
Country:
Australia
Status:
Recruiting
Facility:
Name:
St Vincent's Hospital
Address:
City:
Fitzroy
Country:
Australia
Status:
Recruiting
Facility:
Name:
St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
Address:
City:
Subiaco
Country:
Australia
Status:
Recruiting
Facility:
Name:
Kinghorn Cancer Centre
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Queen Elizabeth Hospital
Address:
City:
Woodville
Country:
Australia
Status:
Recruiting
Facility:
Name:
Medizinische Universitaet Graz
Address:
City:
Graz
Country:
Austria
Status:
Completed
Facility:
Name:
Ordensklinikum Linz GmbH
Address:
City:
Linz
Country:
Austria
Status:
Completed
Facility:
Name:
Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum
Address:
City:
Salzburg
Country:
Austria
Status:
Completed
Facility:
Name:
Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I
Address:
City:
Wien
Country:
Austria
Status:
Completed
Facility:
Name:
Universite Libre de Bruxelles ULB -
Address:
City:
Brussel
Country:
Belgium
Status:
Completed
Facility:
Name:
Universitair Ziekenhuis Gent UZ Gent
Address:
City:
Gent
Country:
Belgium
Status:
Completed
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Completed
Facility:
Name:
Cliniques Univ St Luc - Gastro-Enterology
Address:
City:
Woluwe-Saint-Lambert
Country:
Belgium
Status:
Completed
Facility:
Name:
Tom Baker Cancer Center
Address:
City:
Calgary
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
NSHA, QEII Health Sciences Centre
Address:
City:
Halifax
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
London Regional Cancer Program
Address:
City:
London
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Sunnybrook Health Sciences Centre
Address:
City:
Toronto
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Hôpital Privé Jean Mermoz
Address:
City:
Lyon
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital de la Timone
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire de Nantes CHU de Nantes
Address:
City:
Nantes
Country:
France
Status:
Recruiting
Facility:
Name:
Institute Mutualiste Montsouris
Address:
City:
Paris
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Bordeaux, Hôpital Haut-Lévêque
Address:
City:
Pessac
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Poitiers
Address:
City:
Poitiers
Country:
France
Status:
Recruiting
Facility:
Name:
Charite Universittsmedizin Berlin
Address:
City:
Berlin
Country:
Germany
Status:
Completed
Facility:
Name:
Universitaetsklinikum Carl-Gustav-Carus
Address:
City:
Dresden
Country:
Germany
Status:
Completed
Facility:
Name:
Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf
Address:
City:
Düsseldorf
Zip:
40225
Country:
Germany
Status:
Completed
Facility:
Name:
Universitaetsklinikum Frankfurt
Address:
City:
Frankfurt
Country:
Germany
Status:
Completed
Facility:
Name:
Medizinische Fakultaet der Universitaet Freiburg
Address:
City:
Freiburg
Country:
Germany
Status:
Completed
Facility:
Name:
Medizinische Hochschule Hannover
Address:
City:
Hannover
Country:
Germany
Status:
Completed
Facility:
Name:
Klinikum der Universitaet Muenchen-Grosshadern
Address:
City:
München
Country:
Germany
Status:
Completed
Facility:
Name:
Cork University Hospital
Address:
City:
Cork
Country:
Ireland
Status:
Recruiting
Facility:
Name:
St. James Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Recruiting
Facility:
Name:
St. Vincent's Private Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Recruiting
Facility:
Name:
Policlinico S. Orsola-Malpighi
Address:
City:
Bologna
Country:
Italy
Status:
Recruiting
Facility:
Name:
AOU Careggi
Address:
City:
Florence
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Arcispedale Santa Maria Nuova
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Facility:
Name:
Humanitas Research Hospital
Address:
City:
Rozzano
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
Address:
City:
San Giovanni Rotondo
Country:
Italy
Status:
Recruiting
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino
Address:
City:
Turin
Country:
Italy
Status:
Recruiting
Facility:
Name:
AOUI Verona - Ospedale Borgo Roma
Address:
City:
Verona
Country:
Italy
Status:
Recruiting
Facility:
Name:
CHA Bundang Medical Center
Address:
City:
Seongnam
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Seoul National University
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Yonsei University Health System
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Amsterdam UMC, location AMC
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Completed
Facility:
Name:
Universiteit Maastricht UM - Maastricht University Medical Centre MUMC
Address:
City:
Limburg
Country:
Netherlands
Status:
Completed
Facility:
Name:
Institutul Clinic Fundeni
Address:
City:
Bucarest
Country:
Romania
Status:
Recruiting
Facility:
Name:
Regional Institute of Gastroenterology and Hepatology
Address:
City:
Cluj-Napoca
Country:
Romania
Status:
Recruiting
Facility:
Name:
Centrul de Oncologie Sfantu Necta
Address:
City:
Craiova
Country:
Romania
Status:
Recruiting
Facility:
Name:
Radiotherapy Center Cluj
Address:
City:
Otopeni
Country:
Romania
Status:
Recruiting
Facility:
Name:
Municipal Hospital Ploiesti
Address:
City:
Ploiesti
Country:
Romania
Status:
Recruiting
Facility:
Name:
Complejo Hospitalario Universitario A Coruña (CHUAC)
Address:
City:
A Coruña
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Reina Sofa
Address:
City:
Córdoba
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General de Elche
Address:
City:
Elche
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Maranon
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de octubre
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Navarra
Address:
City:
Pamplona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Marqués de Valdecilla
Address:
City:
Santander
Country:
Spain
Status:
Recruiting
Facility:
Name:
Sahlgrenska University Hospital
Address:
City:
Gothenburg
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Country:
Sweden
Status:
Recruiting
Facility:
Name:
University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)
Address:
City:
Birmingham
Country:
United Kingdom
Status:
Completed
Facility:
Name:
The Beatson Institute West of Scotland Cancer Research
Address:
City:
Glasgow
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Imperial College London
Address:
City:
London
Country:
United Kingdom
Status:
Completed
Facility:
Name:
University College London Hospital NHS Trust
Address:
City:
London
Country:
United Kingdom
Status:
Completed
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Country:
United Kingdom
Status:
Completed
Facility:
Name:
The Newcastle Upon Tyne Hospitals
Address:
City:
Newcastle Upon Tyne
Country:
United Kingdom
Status:
Completed
Start date:
May 3, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Servier Affaires Médicales
Agency class:
Industry
Source:
Servier
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05876754
