Actively Recruiting
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
Led by iOMEDICO AG · Updated on 2025-11-26
100
Participants Needed
7
Research Sites
164 weeks
Total Duration
On this page
Sponsors
I
iOMEDICO AG
Lead Sponsor
S
Servier Deutschland GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed locally advanced or metastatic cholangiocarcinoma with a documented IDH1 R132 mutation by an appropriate diagnostic test
- At least one prior systemic therapy
- Decision made to treat with ivosidenib according to current SmPC
- Signed written informed consent before or within 6 weeks of first ivosidenib dose
- For patients in the PRO module: signed informed consent before treatment start and ability to participate in German-language PRO assessments
- Other criteria according to current SmPC
You will not qualify if you...
- Participation in an interventional clinical trial within 30 days prior to enrollment or concurrent participation in such a trial except during follow-up
- Other contraindications according to current SmPC
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda
Bad Liebenwerda, Germany
Actively Recruiting
2
Caritas Krankenhaus Bad Mergentheim
Bad Mergentheim, Germany
Actively Recruiting
3
Onkologisches Versorgungszentrum Berlin MVZ
Berlin, Germany
Actively Recruiting
4
Onkologie Hannover
Hanover, Germany
Actively Recruiting
5
Onkologie Hof
Hof, Germany
Actively Recruiting
6
Medizinisches Versorgungszentrum Mönchengladbach
Mönchengladbach, Germany
Actively Recruiting
7
ze:roPRAXEN MVZ für Innere Medizin
Weinheim, Germany
Actively Recruiting
Research Team
S
Sina Grebhardt, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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