NCT02989857

Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (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. Participants 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 participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.

Conditions

• Advanced Cholangiocarcinoma
• Metastatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	AG-120	Tablet administered orally
DRUG	Placebo	Tablet administered orally

Timeline

• Start date: 2017-02-20
• Primary completion: 2019-01-31
• Completion: 2021-05-17
• First posted: 2016-12-12
• Last updated: 2024-08-20
• Results posted: 2022-04-13

Locations

49 sites across 6 countries: United States, France, Italy, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study