Using ivosidenib for advanced cholangiocarcinoma with IDH1 mutation after previous treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather real-world data on the effectiveness, quality of life, and safety of ivosidenib in patients with locally advanced or metastatic cholangiocarcinoma who have an IDH1 R132 mutation and have undergone at least one prior systemic treatment. The study will be conducted across multiple centers in Germany, allowing for a diverse patient population. Ivosidenib, an IDH1 inhibitor, was recently approved for this indication, and the study will follow patients receiving this treatment according to the current guidelines.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universitätsklinikum Augsburg, II. Medizinische Klinik
  Augsburg, Germany Recruiting
• Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda
  Bad Liebenwerda, Germany Recruiting
• Caritas Krankenhaus Bad Mergentheim
  Bad Mergentheim, Germany Recruiting
• Onkologische Schwerpunktpraxis Bamberg
  Bamberg, Germany Recruiting
• DRK Kliniken Berlin, Klinik für Innere Medizin
  Berlin, Germany Recruiting
• Onkologisches Versorgungszentrum Berlin MVZ
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Sina Grebhardt, PhD
• Email: sina.grebhardt@iomedico.com
• Phone: +49 761 15 242 31

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.