Trials / Recruiting
RecruitingNCT02074839
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 291 (estimated)
- Sponsor
- Institut de Recherches Internationales Servier · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Untreated AML
- Other IDH1-mutated Positive Hematologic Malignancies
- Myelodysplastic Syndromes
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2014-02-28
- Last updated
- 2025-06-08
Locations
30 sites across 2 countries: United States, France
Source: ClinicalTrials.gov record NCT02074839. Inclusion in this directory is not an endorsement.