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

Recruiting now

Conditions studied: Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT06607302

Run by

iOMEDICO AG

People needed

100

Starts

2024-10-08

Expected to finish

2027-12-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Universitätsklinikum Augsburg, II. Medizinische Klinik — Augsburg, Germany (enrolling)
• Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda — Bad Liebenwerda, Germany (enrolling)
• Caritas Krankenhaus Bad Mergentheim — Bad Mergentheim, Germany (enrolling)
• DRK Kliniken Berlin, Klinik für Innere Medizin — Berlin, Germany (enrolling)
• Onkologisches Versorgungszentrum Berlin MVZ — Berlin, Germany (enrolling)
• Gemeinschaftspraxis Hämatologie - Onkologie — Dresden, Germany (enrolling)
• Onkozentrum Dresden — Dresden, Germany (enrolling)
• Universitätsklinikum Essen, Innere Klinik (Tumorforschung) — Essen, Germany (enrolling)
• Onkologie Hannover — Hanover, Germany (enrolling)
• Onkologie Hof — Hof, Germany (enrolling)
• Medizinisches Versorgungszentrum Mönchengladbach — Mönchengladbach, Germany (enrolling)
• TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Innere Medizin II — München, Germany (enrolling)
• Onkologisches Zentrum Passau — Passau, Germany (enrolling)
• Gemeinschaftspraxis für Internistische Onkologie und Hämatologie — Rheine, Germany (enrolling)
• RoMed Klinikum Rosenheim, Hämatologie und Onkologie — Rosenheim, Germany (enrolling)
• ze:roPRAXEN MVZ für Innere Medizin — Weinheim, Germany (enrolling)

Full record on ClinicalTrials.gov

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