Dysplastic chronic myelomonocytic leukaemia, Myelodysplastic syndromes
Conditions
Brief summary
Incidence of DLTs during the DLT observation period., Incidence, severity, and relationship to IMP, of AEs and SAEs., Changes from baseline in laboratory evaluations, vital signs, physical examinations, and ECG results., Duration of exposure and relative dose intensity.
Detailed description
Objective Response, as assessed by the response criteria corresponding to the different haematologic neoplasms., Duration of Response, Time to Response, Overall Survival, and Time to progression to AML., Plasma concentrations of AZD2962., Plasma PK parameters of AZD2962 (including but not limited to AUC, Cmax, and tmax, as data allow).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of DLTs during the DLT observation period., Incidence, severity, and relationship to IMP, of AEs and SAEs., Changes from baseline in laboratory evaluations, vital signs, physical examinations, and ECG results., Duration of exposure and relative dose intensity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response, as assessed by the response criteria corresponding to the different haematologic neoplasms., Duration of Response, Time to Response, Overall Survival, and Time to progression to AML., Plasma concentrations of AZD2962., Plasma PK parameters of AZD2962 (including but not limited to AUC, Cmax, and tmax, as data allow). | — |
Countries
Spain