About this trial
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 If at any point ivosidenib is made available as a medical prescription at the patient’s site, patients will be withdrawn from the study treatment and patients will be followed to collect data on overall survival.
Patient Profile
Adult (18 years and older) patients with a diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies. Patients must have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease and have received at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects.
Where’s this trial being run?
Cork University Hospital and St James’s Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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QuestionsSummary Data
| Name: | ProvIDHe Trial |
|---|---|
| Number: | 24-50 |
| Full Title: | An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma |
| Principal Investigator: | TBC |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | Servier Affaires Médicales |
| Recruitment Started: |
Global: May 2023 Ireland: TBC |
| Global Recruitment Target: | 220 |
|---|---|
| Ireland Recruitment Target: | 6 |