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

Launched by SERVIER AFFAIRES MÉDICALES · May 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ivosidenib for patients with advanced cholangiocarcinoma, a type of cancer that affects the bile ducts. Specifically, the trial is looking at whether ivosidenib is safe and effective for adults who have already received treatment for their cancer but still have locally advanced or metastatic disease, meaning it has spread to other parts of the body. Eligible participants must have a specific genetic mutation (IDH1) and have already tried at least one other treatment for their cancer.

If you or a loved one qualifies for this study, you will take ivosidenib tablets once a day for 28-day cycles, continuing as long as it helps you and you choose to stay in the study. Throughout the trial, you will have at least six visits to the clinic, and possibly more if you complete additional treatment cycles. The study is currently recruiting patients, and it is important to note that specific eligibility criteria, including certain health conditions and recent treatments, must be met to participate. This trial aims to provide more information about how well this medication works for people with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, 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 blood 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 dose 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
• Exclusion Criteria:
• • Received a prior IDH1 inhibitor
• • Have received a transplant
• • Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
• • Have received hepatic radiation, chemoembolization, and radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1
• • Have ongoing brain metastases requiring steroids
• • Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1
• • Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness
• • Are pregnant or breastfeeding