Relapsed or Refractory Acute Leukemias
Conditions
Brief summary
Phase 1: Occurrence of dose-limiting toxicities (DLTs)., Phase 1: Frequency, duration, and severity of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs)., Phase 1: Incidence and shifts of clinically significant clinical laboratory abnormalities., Phase 1: Change from baseline in other observations related to safety, including electrocardiograms (ECGs), vital signs, ophthalmologic examination findings, and performance status., Phase 1: Pharmacokinetic (PK) parameters: maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the plasma concentration versus time curve (AUC) from time 0 to t (AUC0–t), AUC from time 0 to 24 hours (AUC0–24), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F), and half-life (t1/2)., In Phase 1, the study endpoints will be assessed by dose cohort and overall. and will apply to all arms unless otherwise stated in the endpoint., Phase 2: • CR+CRh rate. • Frequency, duration, and severity of TEAEs, TRAEs, and SAEs. • Incidence and shifts of clinically significant clinical laboratory abnormalities., Phase 2: Change from baseline in other observations related to safety, including ECGs, vital signs, ophthalmologic examination findings, and performance status. For Phase 2, endpoints will be assessed by disease cohort (2A, 2B, and 2C separately) and pooled MLLr population.
Detailed description
Phase 1: PK parameters for tablet vs. capsule evaluation: Cmax, Tmax, AUC0–t, AUC0–24, CL/F, Vz/F, t1/2., Phase 2: Transfusion independence, defined as any transfusion-free period lasting for at least 56 consecutive days, during which the patient is either on SNDX-5613 therapy or after cessation of SNDX-5613 therapy but prior to the start of new therapy., Phase 2: • CRc rate (ie, CR+CRh+CRi+CRp). • ORR (CRc+MLFS+PR). • Time to response. • Duration of response. • Event free survival. • Overall survival. • PK parameters: Cmax, Tmax, AUC0–t, AUC0–24, CL/F, Vz/F, and t1/2.
Interventions
DRUGRevumenib
DRUGSNDX-5613
Sponsors
Syndax Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Occurrence of dose-limiting toxicities (DLTs)., Phase 1: Frequency, duration, and severity of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs)., Phase 1: Incidence and shifts of clinically significant clinical laboratory abnormalities., Phase 1: Change from baseline in other observations related to safety, including electrocardiograms (ECGs), vital signs, ophthalmologic examination findings, and performance status., Phase 1: Pharmacokinetic (PK) parameters: maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the plasma concentration versus time curve (AUC) from time 0 to t (AUC0–t), AUC from time 0 to 24 hours (AUC0–24), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F), and half-life (t1/2)., In Phase 1, the study endpoints will be assessed by dose cohort and overall. and will apply to all arms unless otherwise stated in the endpoint., Phase 2: • CR+CRh | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: PK parameters for tablet vs. capsule evaluation: Cmax, Tmax, AUC0–t, AUC0–24, CL/F, Vz/F, t1/2., Phase 2: Transfusion independence, defined as any transfusion-free period lasting for at least 56 consecutive days, during which the patient is either on SNDX-5613 therapy or after cessation of SNDX-5613 therapy but prior to the start of new therapy., Phase 2: • CRc rate (ie, CR+CRh+CRi+CRp). • ORR (CRc+MLFS+PR). • Time to response. • Duration of response. • Event free survival. • Overall survival. • PK parameters: Cmax, Tmax, AUC0–t, AUC0–24, CL/F, Vz/F, and t1/2. | — |
Countries
France, Germany, Italy, Lithuania, Netherlands, Spain
Outcome results
None listed