Metastatic castration-resistant prostate cancer
Conditions
Brief summary
Phase 1: The incidence of protocol-defined DLTs during the DLT assessment period (first cycle). The DLTs will be characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for AEs [NCI CTCAE version 5.0]), timing in relation to study treatment administration, seriousness, and relationship to study treatment., Phase 1: TEAEs (characterized by type, frequency, severity, timing, seriousness, and relationship to study treatment)., Phase 1: Abnormalities in clinical laboratory parameters, vital sign measurements, and ECGs (characterized by type, frequency, severity, timing, seriousness, and relationship to study treatment)., Phase 1: Changes in ECOG performance status., Phase 2: The proportion of subjects with a prostate-specific antigen decline of >90% (PSA90).
Interventions
Sponsors
Essa Pharma Inc.
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: The incidence of protocol-defined DLTs during the DLT assessment period (first cycle). The DLTs will be characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for AEs [NCI CTCAE version 5.0]), timing in relation to study treatment administration, seriousness, and relationship to study treatment., Phase 1: TEAEs (characterized by type, frequency, severity, timing, seriousness, and relationship to study treatment)., Phase 1: Abnormalities in clinical laboratory parameters, vital sign measurements, and ECGs (characterized by type, frequency, severity, timing, seriousness, and relationship to study treatment)., Phase 1: Changes in ECOG performance status., Phase 2: The proportion of subjects with a prostate-specific antigen decline of >90% (PSA90). | — |
Countries
Belgium, France, Spain
Outcome results
None listed