Metastatic hormone-sensitive prostate cancer
Conditions
Brief summary
Phase I - Safety: DLTs during the first 28 days of combination treatment. Type, frequency and severity of AEs per CTCAE v5.0 and notable values in laboratory values, vital signs, and ECGs - Tolerability: Dose interruptions, dose reductions, drug discontinuations, dose intensity, and duration of exposure to study treatment (all study drugs) Phase II: BCR defined as PSA decline to < 0.2 ng/mL at 6 months, confirmed by a second PSA measurement ≥ 3 weeks later
Detailed description
Phase I: Plasma concentrations of tulmimetostat, darolutamide, and abiraterone, and derived PK parameters including AUC and Cmax Phase II: Radiographic progression free survival (rPFS), Overall survival (OS), Objective response (OR), Best overall response (BOR), Duration of response (DOR), PSA50 and Biochemical Response of <0.1 ng/mL, Time to castration–resistant prostate cancer (CRPC), Phase II: - Safety: Type, frequency and severity of treatment-emergent and treatment-related AEs per CTCAE version 5.0 and notable values in laboratory parameters, vital signs and ECGs - Tolerability: Dose interruptions, dose reductions, drug discontinuations, dose intensity, and duration of exposure to study treatment (all study drugs), Phase II: Plasma concentrations of tulmimetostat and darolutamide., Phase II: TTSSE defined as the time from randomization to the first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I - Safety: DLTs during the first 28 days of combination treatment. Type, frequency and severity of AEs per CTCAE v5.0 and notable values in laboratory values, vital signs, and ECGs - Tolerability: Dose interruptions, dose reductions, drug discontinuations, dose intensity, and duration of exposure to study treatment (all study drugs) Phase II: BCR defined as PSA decline to < 0.2 ng/mL at 6 months, confirmed by a second PSA measurement ≥ 3 weeks later | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Plasma concentrations of tulmimetostat, darolutamide, and abiraterone, and derived PK parameters including AUC and Cmax Phase II: Radiographic progression free survival (rPFS), Overall survival (OS), Objective response (OR), Best overall response (BOR), Duration of response (DOR), PSA50 and Biochemical Response of <0.1 ng/mL, Time to castration–resistant prostate cancer (CRPC), Phase II: - Safety: Type, frequency and severity of treatment-emergent and treatment-related AEs per CTCAE version 5.0 and notable values in laboratory parameters, vital signs and ECGs - Tolerability: Dose interruptions, dose reductions, drug discontinuations, dose intensity, and duration of exposure to study treatment (all study drugs), Phase II: Plasma concentrations of tulmimetostat and darolutamide., Phase II: TTSSE defined as the time from randomization to the first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for | — |
Countries
France, Germany, Hungary, Italy, Spain
Outcome results
None listed