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NCT02989857 · ClinicalTrials.gov registry record · Phase 3
Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
A Phase 3 study of Metastatic Cholangiocarcinoma and Advanced Cholangiocarcinoma, sponsored by Institut de Recherches Internationales Servier.
- Completed
- Registry status
- Phase 3
- Development phase
- 187
- Enrollment target
- 20
- Study locations
NCT02989857 is a Phase 3 study of Metastatic Cholangiocarcinoma and Advanced Cholangiocarcinoma that has completed, run by Institut de Recherches Internationales Servier. The registered enrollment target is 187 participants, above the 57-participant average among 5 other Metastatic Cholangiocarcinoma trials with a reported enrollment target (228% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT02989857, a Phase 3 study of Metastatic Cholangiocarcinoma and Advanced Cholangiocarcinoma, has completed, sponsored by Institut de Recherches Internationales Servier.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 187 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG AG-120
Study Locations (20)
California
- City of Hope Cancer Center - Duarte
- University of California, Irvine - Irvine
- University of Southern California - Los Angeles
- University of California, San Francisco - San Francisco
Illinois
- Northwestern University - Chicago
- University of Chicago Medical Center - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
New York
- Memorial Sloan-Kettering Cancer Center - New York
- Columbia University - New York
Arizona
- Mayo Cancer Center - Scottsdale
Florida
- Mayo Cancer Center - Jacksonville
Maryland
- Johns Hopkins University - Baltimore
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2017-02-20 |
| Est. Completion | 2021-05-17 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02989857
The ClinicalTrials.gov registry entry for NCT02989857 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 57-participant average among 5 other Metastatic Cholangiocarcinoma trials with a reported enrollment target (228% higher). The listed sponsor is Institut de Recherches Internationales Servier, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Cholangiocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02989857 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02989857 about?
NCT02989857 is a clinical study titled "Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)". 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 Sp...
What is the current status of trial NCT02989857?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2017-02-20. Estimated completion is 2021-05-17.
What conditions does trial NCT02989857 study?
This clinical trial studies the following conditions: Metastatic Cholangiocarcinoma, Advanced Cholangiocarcinoma.
What interventions are being tested in trial NCT02989857?
The interventions under investigation include: Placebo (DRUG), AG-120 (DRUG).
Who is sponsoring clinical trial NCT02989857?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02989857 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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