Brief Summary
A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advancedat a late stage, far along, 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.
Intervention / Treatment
- Drug: Ivosidenib Oral Tablet
Inclusion Criteria:
- Diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resectionsurgical removal of tissue or part/all of an organ, 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 bloodthe red bodily fluid that transports oxygen and other nutrients around the body 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 dosethe amount of medication taken 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.