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

Last updated: December 9, 2024
Sponsor: iOMEDICO AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Cancer

Biliary Tract Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT06607302
iOM-040498
  • Ages > 18
  • All Genders

Study Summary

Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease. Ivosidenib was approved by European Medicines Agency (EMA) in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.

The prospective, multicenter, observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany. Ivosidenib will be administered according to the current SmPC. Thus, IDHIRA will generate real-world evidence on effectiveness, quality of life (QoL) and safety of ivosidenib.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older.

  • Histologically confirmed locally advanced or metastatic CCC with a documented IDH1R132 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 forpatients 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

Exclusion Criteria:

  • Participation in an interventional clinical trial within 30 days prior to enrolmentor concurrent participation in an interventional clinical trial except for thefollow-up period.

  • Other contraindications according to current SmPC.

Study Design

Total Participants: 100
Study Start date:
October 08, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Caritas Krankenhaus Bad Mergentheim

    Bad Mergentheim,
    Germany

    Active - Recruiting

  • Onkologisches Versorgungszentrum Berlin MVZ

    Berlin,
    Germany

    Active - Recruiting

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