Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
Public ClinicalTrials.gov record NCT02989857. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02989857
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 187 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 20, 2017 (Actual)
- Primary completion
- Jan 31, 2019 (Actual)
- Completion
- May 17, 2021 (Actual)
- Last update posted
- Aug 20, 2024
2017 – 2021
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Cancer Center | Scottsdale | Arizona | 85054 | — |
| City of Hope Cancer Center | Duarte | California | 91010 | — |
| University of California, Irvine | Irvine | California | 92868 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| University of California, San Francisco | San Francisco | California | 94158 | — |
| Mayo Cancer Center | Jacksonville | Florida | 32224 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Mayo Cancer Center | Rochester | Minnesota | 55905 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | — |
| Columbia University | New York | New York | 10032 | — |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Gibbs Cancer Center | Spartanburg | South Carolina | 29303 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| University of Texas, SouthWestern | Dallas | Texas | 75390 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| University of Wisconsin, Carbone Cancer Center | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02989857, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2024 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02989857 live on ClinicalTrials.gov.