Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
Conditions
Brief summary
Phase Ib: Safety and tolerability will be evaluated in terms of DLTs, AEs/SAEs, vital signs, clinical chemistry/haematology/glucose metabolism parameters, and ECG parameters.The measures of interest are subject incidence rates, absolute values and change from baseline over time., Phase III: PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause in the overall population, the altered population, and the confirmed non-altered population.
Detailed description
Phase Ib: 1. Palbociclib PK parameters: Cmax, AUC0-72h (Cycle 0), AUC0-24h (Cycle 1), Cmin (Cycle 1); Ribociclib PK parameters: Cmax, AUC0-t (Cycle 0), AUC0-24h (Cycle 1), Cmin (Cycle 1); Abemaciclib PK parameters: Cmax, AUC0-t (Cycle 0), AUC0-12h (Cycle 1), Cmin (Cycle 1) 2. Capivasertib PK parameters: Cmax, AUC0-12h, Cmin, 3. Plasma PK parameters derived from a population PK model, as permitted by the data. 4. ORR 5. CBR at 24 weeks 6. DoR 7. PFS, Phase III: For overall population, in altered population and in confirmed non-altered population: 1. OS 2. ORR For overall population only: 3. PFS2 4. DoR 5. CBR at 24 weeks 6. TTD of physical functioning (EORTC QLQ-C30) 7. TTD of GHS/QoL 8. PGI-TT, 8. Plasma concentration of capivasertib pre-dose (Ctrough), and post-dose (C1h, C2h, and C4h) in the overall population (participants randomised to Capivasertib), 9. The number of participants with adverse events (data will include clinical observations, ECG parameters, clinical chemistry, hematology, glucose metabolism parameters and vital signs) 10. The number of participants with serious adverse events (data will include clinical observations, ECG parameters, clinical chemistry, hematology, glucose metabolism parameters and vital signs)
Interventions
DRUGCapivasertib
DRUGVerzenios 50 mg film-coated tablets
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase Ib: Safety and tolerability will be evaluated in terms of DLTs, AEs/SAEs, vital signs, clinical chemistry/haematology/glucose metabolism parameters, and ECG parameters.The measures of interest are subject incidence rates, absolute values and change from baseline over time., Phase III: PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause in the overall population, the altered population, and the confirmed non-altered population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase Ib: 1. Palbociclib PK parameters: Cmax, AUC0-72h (Cycle 0), AUC0-24h (Cycle 1), Cmin (Cycle 1); Ribociclib PK parameters: Cmax, AUC0-t (Cycle 0), AUC0-24h (Cycle 1), Cmin (Cycle 1); Abemaciclib PK parameters: Cmax, AUC0-t (Cycle 0), AUC0-12h (Cycle 1), Cmin (Cycle 1) 2. Capivasertib PK parameters: Cmax, AUC0-12h, Cmin, 3. Plasma PK parameters derived from a population PK model, as permitted by the data. 4. ORR 5. CBR at 24 weeks 6. DoR 7. PFS, Phase III: For overall population, in altered population and in confirmed non-altered population: 1. OS 2. ORR For overall population only: 3. PFS2 4. DoR 5. CBR at 24 weeks 6. TTD of physical functioning (EORTC QLQ-C30) 7. TTD of GHS/QoL 8. PGI-TT, 8. Plasma concentration of capivasertib pre-dose (Ctrough), and post-dose (C1h, C2h, and C4h) in the overall population (participants randomised to Capivasertib), 9. The number of participants with adverse events (data will include clinical observations, ECG parameters, clinical chemist | — |
Countries
Belgium, Denmark, France, Germany, Italy, Poland, Spain, Sweden
Outcome results
None listed