RecruitingNCT06607302

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

Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - a Prospective, Multicenter, Observational Study in Germany


Sponsor

iOMEDICO AG

Enrollment

100 participants

Start Date

Oct 8, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study follows patients with advanced bile duct cancer (cholangiocarcinoma) who have a specific genetic mutation called IDH1 R132 and are being treated with ivosidenib, a targeted therapy approved for this mutation. The study collects real-world data on how well the treatment works and how patients experience it. **You may be eligible if...** - You are 18 years or older - You have locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with a confirmed IDH1 R132 mutation - You have received at least one prior systemic treatment - Your doctor has decided to treat you with ivosidenib per standard prescribing guidelines - You have given written informed consent within 6 weeks of your first ivosidenib dose **You may NOT be eligible if...** - You do not have an IDH1 R132 mutation - You have not had prior therapy - You do not meet the prescribing guidelines for ivosidenib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(16)

Universitätsklinikum Augsburg, II. Medizinische Klinik

Augsburg, Germany

Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda

Bad Liebenwerda, Germany

Caritas Krankenhaus Bad Mergentheim

Bad Mergentheim, Germany

DRK Kliniken Berlin, Klinik für Innere Medizin

Berlin, Germany

Onkologisches Versorgungszentrum Berlin MVZ

Berlin, Germany

Gemeinschaftspraxis Hämatologie - Onkologie

Dresden, Germany

Onkozentrum Dresden

Dresden, Germany

Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

Essen, Germany

Onkologie Hannover

Hanover, Germany

Onkologie Hof

Hof, Germany

Medizinisches Versorgungszentrum Mönchengladbach

Mönchengladbach, Germany

TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Innere Medizin II

München, Germany

Onkologisches Zentrum Passau

Passau, Germany

Gemeinschaftspraxis für Internistische Onkologie und Hämatologie

Rheine, Germany

RoMed Klinikum Rosenheim, Hämatologie und Onkologie

Rosenheim, Germany

ze:roPRAXEN MVZ für Innere Medizin

Weinheim, Germany

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NCT06607302


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