Condition: Cholangiocarcinoma · Sponsor: iOMEDICO AG
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.
This description comes directly from the study's public registry record.
Sina Grebhardt, PhD · +49 761 15 242 31 · sina.grebhardt@iomedico.com
Always discuss trial participation with your own doctor first.
| Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda | Bad Liebenwerda, Germany | Recruiting |
| Caritas Krankenhaus Bad Mergentheim | Bad Mergentheim, Germany | Recruiting |
| Onkologisches Versorgungszentrum Berlin MVZ | Berlin, Germany | Recruiting |
| Gemeinschaftspraxis Hämatologie - Onkologie | Dresden, Germany | Recruiting |
| Onkozentrum Dresden | Dresden, Germany | Recruiting |
| Universitätsklinikum Essen, Innere Klinik (Tumorforschung) | Essen, Germany | Recruiting |
| Onkologie Hannover | Hanover, Germany | Recruiting |
| Onkologie Hof | Hof, Germany | Recruiting |
| Medizinisches Versorgungszentrum Mönchengladbach | Mönchengladbach, Germany | Recruiting |
| TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Innere Medizin II | München, Germany | Recruiting |
| Gemeinschaftspraxis für Internistische Onkologie und Hämatologie | Rheine, Germany | Recruiting |
| RoMed Klinikum Rosenheim, Hämatologie und Onkologie | Rosenheim, Germany | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06607302