An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma (ProvIDHe)

NCT05876754 PHASE3 RECRUITING

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.

Details

Lead sponsor	Servier Affaires Médicales
Phase	PHASE3
Status	RECRUITING
Enrolment	220
Start date	Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Dec 01 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Cholangiocarcinoma

Interventions

• Ivosidenib Oral Tablet

Countries

France, Italy, Japan, Netherlands, Belgium, Austria, Sweden, Ireland, United Kingdom, Germany, South Korea, Romania, Canada, Australia, Armenia, Spain