Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Condition(s) studied
Investigational drug(s) / intervention(s)
AG-120: AG-120 administered continuously as a single agent dosed orally every day of a 28-day cycle. Subjects may continue treatment with AG-120 until disease progression, development of other unacceptable toxicity or hematopoietic stem cell transplant.
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.
Eligibility
Primary outcome measure(s)
- Safety/tolerability: incidence of adverse events. — up to 26 weeks, on average
- Maximum Tolerated Dose and/or the recommended Phase II dose of AG-120 in subjects with advanced hematologic malignancies. — up to 26 weeks, on average
- Assess clinical activity of AG-120 in subjects with relapsed or refractory AML who are enrolled in the Expansion Phase. — up to 26 weeks, on average
- Safety/tolerability of treatment with AG-120 in subjects with relapsed or refractory myelodysplastic syndrome. — up to 26 weeks, on average
- Assess clinical activity of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome. — up to 26 weeks, on average
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Active Not Recruiting |
| Mayo Clinic-AZ | Phoenix | Arizona | Terminated |
| City of Hope | Duarte | California | Active Not Recruiting |
| University of California-Los Angeles | Los Angeles | California | Terminated |
| University of California-San Francisco | San Francisco | California | Terminated |
| University of Colorado Denver | Aurora | Colorado | Terminated |
| Mayo Clinic-Jacksonville | Jacksonville | Florida | Terminated |
| University of Miami | Miami | Florida | Terminated |
| Moffit Cancer Center | Tampa | Florida | Active Not Recruiting |
| Emory University | Atlanta | Georgia | Active Not Recruiting |
| Northwestern University Medical Hospital | Chicago | Illinois | Terminated |
| John Hopkins Cancer Center | Baltimore | Maryland | Active Not Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Terminated |
| Dana Farber Cancer Institute | Boston | Massachusetts | Terminated |
| Karmanos Cancer Center | Detroit | Michigan | Terminated |
| Washington University | St Louis | Missouri | Terminated |
| Memorial Sloan Kettering Cancer Center | New York | New York | Active Not Recruiting |
| Cornell Cancer Center | New York | New York | Terminated |
| Duke Cancer Center | Durham | North Carolina | Terminated |
| Cleveland Clinic | Cleveland | Ohio | Withdrawn |
| Ohio State University | Columbus | Ohio | Terminated |
| Oregon Health and Science University | Portland | Oregon | Terminated |
| Medical University of South Carolina | Charleston | South Carolina | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | Terminated |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Hopital La Timone | Marseille | France | Terminated |
| Hopital Haut-Leveque | Pessac | France | Recruiting |
| Central Lyon Sud | Pierre-Bénite | France | Recruiting |
| Institute Gustave Roussly (IGR) | Villejuif | France | Recruiting |
More Institut de Recherches Internationales Servier trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02074839 on ClinicalTrials.gov ↗ ← All trials in France