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Kütüphanede Ara Ara
Altai Protocol Library

New Indication: Ivosidenib for IDH1 mutant advanced cholangiocarcinoma

New Indication: Ivosidenib for IDH1 mutant advanced cholangiocarcinoma
Study:
  • Double-blind, randomized Phase III trial (ClarIDHy)
  • Advanced cholangiocarcinoma with IDH1 mutation, progressed after 1 or 2 lines of therapy
  • Ivosidenib 500 mg daily (n=124) vs. placebo (n=61)
Efficacy:
  • Median PFS: 2.7 vs. 1.4 mos (HR: 0.37 [0.25-0.54])
  • Median OS: 10.3 vs. 7.5 mos (HR: 0.79 [0.56-1.12])
Safety:
  • Grade >= 3 AEs: Ascites (9% vs. 7%), anemia (7% vs. none), increased serum bilirubin (6% vs. 2%), hyponatremia (6% vs. 10%)

JAMA Oncol. Published online September 23, 2021

Zhu AX, et al. Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial

https://doi.org/10.1001/jamaoncol.2021.3836

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Altai Chemo Planner employs Altai Protocol Library that includes over 1000 chemotherapy protocols for both Hematology and Oncology. You can find major guidelines' protocols, parenteral, and oral, in the library. Altai Protocol Library is frequently and regularly updated.

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