Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
NCT ID: NCT06607302
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-10-08
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Other contraindications according to current SmPC.
18 Years
ALL
No
Sponsors
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Servier Deutschland GmbH
INDUSTRY
iOMEDICO AG
INDUSTRY
Responsible Party
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Locations
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Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda
Bad Liebenwerda, , Germany
Caritas Krankenhaus Bad Mergentheim
Bad Mergentheim, , Germany
Onkologisches Versorgungszentrum Berlin MVZ
Berlin, , Germany
Onkologie Hannover
Hanover, , Germany
Onkologie Hof
Hof, , Germany
Medizinisches Versorgungszentrum Mönchengladbach
Mönchengladbach, , Germany
ze:roPRAXEN MVZ für Innere Medizin
Weinheim, , Germany
Countries
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Central Contacts
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Facility Contacts
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Stephan Kreher, PD Dr. med.
Role: primary
Matthias Raab, Dr.
Role: primary
Reinhard Musch
Role: primary
Haytham Kamal, Dr. med.
Role: primary
Markus Kapp, Dr. med.
Role: primary
Ludger Sellmann, PD Dr. med.
Role: primary
Manuel Zink, Dr. med.
Role: primary
References
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Michl M, Hagemeyer N, Looss M, Grebhardt S, Ringwald K, Potthoff K. IDHIRA: a prospective, observational study on ivosidenib in patients with IDH1 R132-mutated advanced cholangiocarcinoma. Future Oncol. 2025 Apr;21(9):1057-1064. doi: 10.1080/14796694.2025.2470609. Epub 2025 Mar 3.
Other Identifiers
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iOM-040498
Identifier Type: -
Identifier Source: org_study_id
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