Practice-entering research
ClarIDHy — ivosidenib in IDH1-mutant cholangiocarcinoma
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of AG-120 in Previously Treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
- Phase
- Phase III
- Recruitment
- Completed
- Results maturity
- Final analysis
- Publication
- Peer-reviewed
- Regulatory approval
- FDA approval (US)
- NCT
- NCT02989857
- Registry checked
- 2026-10-29
- Editorial update
- 2026-10-29
Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.
For patients
What is being studied? If an IDH1 mutation is present in bile-duct cancer, a targeted pill may be an option. Molecular testing is required.
Why promising? Randomized PFS benefit of an oral IDH1 inhibitor in molecularly selected CCA.
What is not proven? IDH1 wild-type; universal first-line role.
Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.
For clinicians
Lancet Oncol ClarIDHy; crossover affects OS interpretation.
Cancer / population: Biliary tract — Önceden tedavi, rezeke edilemeyen / metastatik IDH1-mutant CCA
Intervention: Ivosidenib
Primary endpoint: PFS
Limitations: Seçilmiş biyobelirteç popülasyonu; çapraz geçiş.
Landmark Atlas links
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