Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study

Launched by IOMEDICO AG · Sep 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called ivosidenib for patients with locally advanced or metastatic cholangiocarcinoma, a rare and aggressive cancer of the bile duct. The trial is specifically looking at patients who have a certain genetic mutation (IDH1 R132 mutation) and who have already received at least one previous treatment. The goal is to gather real-world data on how effective and safe ivosidenib is, as well as how it impacts patients' quality of life.

To participate in this trial, you need to be 18 years or older and have a confirmed diagnosis of cholangiocarcinoma with the specific mutation. You must have already been treated with at least one other therapy. Participants will receive ivosidenib as per the standard treatment guidelines, and you'll be monitored for your health and well-being throughout the study. This trial is currently recruiting participants, and your involvement will help researchers understand more about this treatment in a broader group of patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older.
• • Histologically confirmed locally advanced or metastatic CCC with a documented IDH1 R132 mutation diagnosed by an appropriate diagnostic test
• • Patients must have at least one prior systemic therapy
• • Decision for treatment with ivosidenib according to current SmPC.
• • Signed written informed consent before or within 6 weeks of first ivosidenib dose (inclusion of patients up to 6 weeks after first ivosidenib intake is allowed for patients not participating in the PRO module)
• * For patients participating in the PRO module (optional):
• • Dated signature of informed consent form before start of study treatment.
• • Willingness and capability to participate in PRO assessment in German language.
• • Other criteria according to current SmPC.
• Exclusion Criteria:
• • Participation in an interventional clinical trial within 30 days prior to enrolment or concurrent participation in an interventional clinical trial except for the follow-up period.
• • Other contraindications according to current SmPC.