At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Documented IDH1 R132 gene-mutated advanced hematologic malignancy
- ✓Amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling
- ✓ECOG Performance Status 0 to 2
- ✕HSCT within 60 days of first dose, or on immunosuppressive therapy post-HSCT at screening, or with clinically significant GVHD
- ✕Systemic anticancer therapy or radiotherapy <14 days prior to first dose (hydroxyurea allowed)
- ✕Investigational agent <14 days prior to first dose
- ✕Pregnant or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating AG-120 for Relapsed or Refractory Acute Myeloid Leukemia (AML) and 3 related conditions. Currently recruiting, targeting 291 participants across 30 sites in 2 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
AG-120 administered continuously as a single agent dosed orally every day of a 28-day cycle.
Interventions
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.