Status:
RECRUITING
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
Lead Sponsor:
iOMEDICO AG
Collaborating Sponsors:
Servier Deutschland GmbH
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06607302
Start Date
October 8 2024
End Date
December 1 2027
Last Update
November 26 2025
Active Locations (7)
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1
Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda
Bad Liebenwerda, Germany
2
Caritas Krankenhaus Bad Mergentheim
Bad Mergentheim, Germany
3
Onkologisches Versorgungszentrum Berlin MVZ
Berlin, Germany
4
Onkologie Hannover
Hanover, Germany