Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
Status:
Completed
Trial end date:
2021-05-17
Target enrollment:
Participant gender:
Summary
Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled
study of orally administered AG-120. Subjects, all personnel involved in the evaluation of
subjects' response to treatment (e.g., Investigators, study coordinators, study pharmacists),
and designated Sponsor team members will be blinded to study treatment. Subjects are required
to have a histologically-confirmed diagnosis of IDH1 gene-mutated cholangiocarcinoma that is
not eligible for curative resection, transplantation, or ablative therapies prior to
enrollment.IDH1 mutation testing will be performed at participating investigative sites.
Subjects must have progression of disease and have received at least 1 but not more than 2
prior treatment regimens for advanced disease (nonresectable or metastatic). All subjects
must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy
regimen.