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

NCT02989857 PHASE3 COMPLETED Results posted

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.

Details

Lead sponsor	Institut de Recherches Internationales Servier
Phase	PHASE3
Status	COMPLETED
Enrolment	187
Start date	Mon Feb 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon May 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Advanced Cholangiocarcinoma
• Metastatic Cholangiocarcinoma

Interventions

• AG-120
• Placebo

Countries

France, Italy, United Kingdom, South Korea, United States, Spain