Phase 3b Study of Ivosidenib for Patients With Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
A Phase 3b research study to collect additional data that ivosidenib is safe and effective in
adult patients with advanced or metastatic bile duct cancer, cholangiocarcinoma (CCA). All
patients who meet enrollment 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.