Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
Ivosidenib + capecitabine is a combination regimen being evaluated in the adjuvant setting for patients with resected biliary tract cancer (BTC) harboring IDH1 mutations. **Ivosidenib** is an oral small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme, which is responsible for the production of the oncometabolite 2-hydroxyglutarate (2-HG). By inhibiting mutant IDH1, ivosidenib restores normal cellular differentiation and inhibits tumor cell proliferation. **Capecitabine** is an oral fluoropyrimidine carbamate that acts as a systemic prodrug of 5-fluorouracil (5-FU). It is converted to 5-FU within the tumor by thymidine phosphorylase, where it subsequently inhibits DNA synthesis and slows tumor growth. This combination is specifically being tested in the **SAFIR-IMPACT BTC** phase 3 umbrella trial, sponsored by **Unicancer**, to determine if matched targeted therapy is superior to standard-of-care adjuvant chemotherapy in preventing cancer recurrence after surgical resection.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on ivosidenib + capecitabine.