Open-Label Early Access Phase 3b Study of Ivosidenib in Patients with Cholangiocarcinoma
Research type
Research Study
Full title
An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
IRAS ID
1006549
Contact name
Alice Vermeire
Contact email
Sponsor organisation
SERVIER AFFAIRES MÉDICALES
Clinicaltrials.gov Identifier
Research summary
The main purpose of this study is to provide early access to the study drug, ivosidenib, to participants with cholangiocarcinoma (CCA) (a rare type of cancer that forms in the bile duct of the digestive system), with a specific gene mutation, that has spread into nearby areas of the body (locally advanced) or has spread to other areas of the body (metastatic), and they have received at least 1 prior line of systemic treatment. There are around 1,000 new cases every year in the UK.
The safety and efficacy of the study drug are already proven. This will also be an opportunity to learn more about how safe the study drug is and how well the study drug works when taken daily. The study is an open-label study, in which the participant, the study doctor, and any other people involved in this study will know which dose of study drug the participant receives.
The study will take place in approximately 60 centres in about 10 countries in Europe and Australia, with about 220 people with CCA disease participating. This study is divided into 3 periods: a screening period, a treatment period, and a follow-up period. The screening visit will last about 1 hour, but all other visits will last about 1 to 2 hours. Participants will need to come to the study centre at least 6 times during the screening and treatment period. Some visits may take place at the participant's home, if necessary.
Participants can take the study drug as long as their study doctor determines that they are benefitting from treatment, or until they choose to stop.
After their last scheduled dose of study drug, participants will enter a follow-up period for up to 18 months where their study doctor will be in contact approximately every 6 months to find out about anticancer therapies that they may have taken.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0272
Date of REC Opinion
12 Jan 2023
REC opinion
Further Information Favourable Opinion