Table 2 A selection of active studies evaluating epigenetic modifiers in AML
Protocol title | NCT identifier |
|---|---|
Agent: HDAC inhibitors | |
 A phase 2 study of temozolomide plus vorinostat in patients with relapse/refractory acute myeloid leukemia (AML) (Sponsor: Stanford University) | NCT01550224 |
 Phase I/II study with oral panobinostat maintenance therapy following allogeneic stem cell transplantation in patients with high risk MDS or AML (PANOBEST) (Sponsor: Johann Wolfgang Goethe University Hospital) | NCT01451268 |
 A phase 1 study of AZD1775 in combination with belinostat in relapsed and refractory myeloid malignancies and selected untreated patients with acute myeloid leukemia (Sponsor: National Cancer Institute) | NCT02381548 |
 A phase I and dose expansion cohort study of panobinostat in combination with fludarabine and cytarabine in pediatric patients with refractory or relapsed acute myeloid leukemia or myelodysplastic syndrome (Sponsor: St. Jude Children’s Research Hospital) | NCT02676323 |
Agent: BET inhibitors | |
 A phase 1/2, open-label, dose-escalation, safety and tolerability study of INCB054329 in subjects with advanced malignancies (Sponsor: Incyte Corporation) | NCT02431260 |
 A phase I/II open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in subjects with relapsed, refractory hematologic malignancies (Sponsor: GlaxoSmithKline) | NCT01943851 |
 A phase 1 dose escalation, multicenter, open-label, safety, pharmacokinetic and pharmacodynamic study of FT-1101 in patients with relapsed or refractory hematologic malignancies (Sponsor: Forma Therapeutics, Inc.) | NCT02543879 |
 A dose escalation study of RO6870810/TEN-010 in patients with acute myeloid leukemia and myelodysplastic syndrome (Sponsor: Hoffmann-La Roche) | NCT02308761 |
 A phase 1/2, open-label, dose-escalation, safety and tolerability study of INCB054329 in subjects with advanced malignancies (Sponsor: Incyte Corporation) | NCT02431260 |
Agent: LSD1 inhibitors | |
 A phase 1/2, open-label, dose-escalation/dose-expansion, safety and tolerability study of INCB059872 in subjects with advanced malignancies (Sponsor: Incyte Corporation) | NCT02712905 |
 A phase I open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2879552 given orally in subjects with relapsed/refractory acute myeloid leukemia (Sponsor: GlaxoSmithKline) | NCT02177812 |
 A multi-center, open label study to assess the safety, steady-state pharmacokinetics and pharmacodynamics of IMG-7289 with and without ATRA (Tretinoin) in patients with advanced myeloid malignancies (Sponsor: Imago BioSciences, Inc.) | NCT02842827 |
Agent: guadecitabine | |
 A phase 3, multicenter, randomized, open-label study of guadecitabine (SGI-110) versus treatment choice in adults with previously treated acute myeloid leukemia (Sponsor: Astex Pharmaceuticals) | NCT02920008 |
 A phase 3, multicenter, open-label, randomized study of SGI-110 versus treatment choice (TC) in adults with previously untreated acute myeloid leukemia (AML) who are not considered candidates for intensive remission induction chemotherapy (Sponsor: Astex Pharmaceuticals) | NCT02348489 |
 A phase Ib study evaluating the safety and pharmacology of atezolizumab (Anti-PD-L1 Antibody) administered in combination with immunomodulatory agents in patients with acute myeloid leukemia (Sponsor: Hoffmann-La Roche) | NCT02892318 |
Agent: IDH inhibitors | |
 An open-label, non-randomized, multicenter phase I study to determine the maximum tolerated and/or recommended phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML) (Sponsor: Bayer) | NCT03127735 |
 A phase 1, multicenter, open-label, safety study of AG-120 or AG-221 in combination with induction therapy and consolidation therapy in patients with newly diagnosed acute myeloid leukemia with an IDH1 and/or IDH2 mutation (Sponsor: Agios Pharmaceuticals, Inc.) | NCT02632708 |
 A phase 3, multicenter, double-blind, randomized, placebo-controlled study of AG-120 in combination with azacitidine in subjects ≥18 years of age with previously untreated acute myeloid leukemia with an IDH1 mutation (Sponsor: Agios Pharmaceuticals, Inc.) | NCT03173248 |
 A phase 1/1b, multicenter, open-label, dose-escalation study of FT-2102 as a single agent and in combination with azacitidine in patients with acute myeloid leukemia or myelodysplastic syndrome with an IDH1 mutation (Sponsor: Forma Therapeutics, Inc.) | NCT02719574 |