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

NCT02989857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2024-08-20

Study results available
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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

DRUG

AG-120

Tablet administered orally

DRUG

Placebo

Tablet administered orally

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    lead OTHER

Principal Investigators

  • Medical Affairs Servier Pharmaceuticals LLC · Servier Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2019-01-31
Completion
2021-05-17
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02989857 on ClinicalTrials.gov