Patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome /Acute Myeloid Leukemia (MDS/AML) or Chronic Myelomonocytic Leukemia (CMML)
Conditions
Brief summary
Part 1A: - dose limiting toxicities (DLTs) associated with S241656 during the first cycle of treatment - Incidence, severity and duration of AEs and SAEs, changes in safety laboratory results, changes in the physical examination, and in other clinically relevant safety parameters - Dose reductions/interruptions/delays or study withdrawal due to AEs, Part 1B: - Plasma PK parameters of S241656 and its metabolite S243796 including Cmax, Tmax, t1/2, AUC with and without posaconazole - DLTs associated with S241656 during the first cycle of treatment, Part 1B: - Incidence, severity and duration of AEs and SAEs, changes in safety laboratory results, changes in the physical examination, and other clinically relevant safety parameters, as well as dose reductions/interruptions/delays or study withdrawal due to AEs
Detailed description
Part 1A: PK parameters of S241656 and its metabolite S243796 including but not limited to maximum concentration (Cmax), time to maximum concentration (Tmax), area under the curve (AUC), and terminal half-life (t½), Part 1A: - complete remission (CR) - complete remission with incomplete hematologic recovery (Cri) - morphologic leukemia-free state (MLFS) - complete remission with partial hematologic recovery (CRh) - partial remission (PR) - overall response (OR), composite complete remission (CRc) - RBC and platelet transfusion independence for at least 8 weeks, Part 1A: - duration of response (DOR) - time to response (TTR) - event-free survival (EFS) - overall survival (OS) - Marrow response - Clinical benefit: erythroid-, neutrophil-, platelet- or spleen-response - Clinical efficacy parameters including but not limited to OR, CR, DOR, and EFS, Part 1A: - Safety and tolerability parameters as defined in the study protocol. - Pharmacokinetic (PK) parameters as defined in the study protocol, Part 1B: - CR - Cri - MLFS - CRh - PR - OR - CRc - RBC and platelet transfusion independence for at least 8 weeks - DOR - TTR - EFS - OS - Marrow response - Clinical benefit: erythroid-, neutrophil-, platelet- or spleen-response
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1A: - dose limiting toxicities (DLTs) associated with S241656 during the first cycle of treatment - Incidence, severity and duration of AEs and SAEs, changes in safety laboratory results, changes in the physical examination, and in other clinically relevant safety parameters - Dose reductions/interruptions/delays or study withdrawal due to AEs, Part 1B: - Plasma PK parameters of S241656 and its metabolite S243796 including Cmax, Tmax, t1/2, AUC with and without posaconazole - DLTs associated with S241656 during the first cycle of treatment, Part 1B: - Incidence, severity and duration of AEs and SAEs, changes in safety laboratory results, changes in the physical examination, and other clinically relevant safety parameters, as well as dose reductions/interruptions/delays or study withdrawal due to AEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1A: PK parameters of S241656 and its metabolite S243796 including but not limited to maximum concentration (Cmax), time to maximum concentration (Tmax), area under the curve (AUC), and terminal half-life (t½), Part 1A: - complete remission (CR) - complete remission with incomplete hematologic recovery (Cri) - morphologic leukemia-free state (MLFS) - complete remission with partial hematologic recovery (CRh) - partial remission (PR) - overall response (OR), composite complete remission (CRc) - RBC and platelet transfusion independence for at least 8 weeks, Part 1A: - duration of response (DOR) - time to response (TTR) - event-free survival (EFS) - overall survival (OS) - Marrow response - Clinical benefit: erythroid-, neutrophil-, platelet- or spleen-response - Clinical efficacy parameters including but not limited to OR, CR, DOR, and EFS, Part 1A: - Safety and tolerability parameters as defined in the study protocol. - Pharmacokinetic (PK) parameters as defined in the study p | — |