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NCT02074839 · ClinicalTrials.gov registry record · Phase 1
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
A Phase 1 study of Myelodysplastic Syndromes and Untreated AML, sponsored by Institut de Recherches Internationales Servier.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 291
- Enrollment target
- 20
- Study locations
NCT02074839 is a Phase 1 study of Myelodysplastic Syndromes and Untreated AML that is actively recruiting participants, run by Institut de Recherches Internationales Servier. The registered enrollment target is 291 participants, roughly in line with the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target. The trial reports 20 study locations across 14 states.
The verdict
NCT02074839, a Phase 1 study of Myelodysplastic Syndromes and Untreated AML, is actively recruiting participants, sponsored by Institut de Recherches Internationales Servier.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 291 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Conditions Studied
Interventions
- DRUG AG-120
Study Locations (20)
California
- City of Hope - Duarte
- University of California-Los Angeles - Los Angeles
- University of California-San Francisco - San Francisco
Florida
- Mayo Clinic-Jacksonville - Jacksonville
- University of Miami - Miami
- Moffit Cancer Center - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
- Cornell Cancer Center - New York
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic-AZ - Phoenix
Colorado
- University of Colorado Denver - Aurora
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02074839
The ClinicalTrials.gov registry entry for NCT02074839 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 291 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target. The listed sponsor is Institut de Recherches Internationales Servier, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which AG-120 is the first listed.
NCT02074839 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02074839 about?
NCT02074839 is a clinical study titled "Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation". The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will rec...
What is the current status of trial NCT02074839?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 291 participants. The study started on 2014-03-01. Estimated completion is 2026-03.
What conditions does trial NCT02074839 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Untreated AML, Relapsed or Refractory Acute Myeloid Leukemia (AML), Other IDH1-mutated Positive Hematologic Malignancies.
What interventions are being tested in trial NCT02074839?
The interventions under investigation include: AG-120 (DRUG).
Who is sponsoring clinical trial NCT02074839?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02074839 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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