advanced prostate cancer
Conditions
Brief summary
Degarelix plasma PK profile and PK parameters over 12 weeks after Debio 4228 dosing, including but not limited to: - Maximum concentration (Cmax) - Area under the concentration-time curve over 12 weeks (AUC84d) - Concentration at 12 weeks (C84d) This will be derived for each treatment period., Testosterone serum concentration profile from Day 1 to Day 85 for all cohorts and from Day 85 to Day 169 in case of Cohort 3
Detailed description
Achievement and maintenance of testosterone castration (testosterone level <50 ng/dL and <20 ng/dL) from Day 29 to Day 85 for all cohorts, Maintenance of testosterone castration (testosterone level <50 ng/dL and <20 ng/dL) from Day 29 to Day 169 for Cohort 3, Time to castration (testosterone level <50 ng/dL and <20 ng/dL), Investigator’s assessment (4-point rating scale) of erythema, swelling, and induration at the injection site immediately after Debio 4228 injection, 2 hours, and 24 hours (Day 2) after Debio 4228 injection, Participants’ self-assessment of pain at the injection site immediately after Debio 4228 injection, 2 hours, and 24 hours (Day 2) after Debio 4228 injection using Numeric Pain Rating Scale (NPRS), Incidence and severity of treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs, adverse events of special interest (AESIs), death, and TEAEs leading to treatment delay, and/or discontinuation, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0;, Percentage of change of PSA over time (per scheduled timepoint), Time course of changes of LH and FSH (per scheduled timepoint), Safety laboratory parameters and related severity based on NCI-CTCAE version 5.0, Changes from baseline in vital signs, weight, and electrocardiogram (ECG)
Interventions
DRUGDebio 4228
Sponsors
Debiopharm International SA
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degarelix plasma PK profile and PK parameters over 12 weeks after Debio 4228 dosing, including but not limited to: - Maximum concentration (Cmax) - Area under the concentration-time curve over 12 weeks (AUC84d) - Concentration at 12 weeks (C84d) This will be derived for each treatment period., Testosterone serum concentration profile from Day 1 to Day 85 for all cohorts and from Day 85 to Day 169 in case of Cohort 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement and maintenance of testosterone castration (testosterone level <50 ng/dL and <20 ng/dL) from Day 29 to Day 85 for all cohorts, Maintenance of testosterone castration (testosterone level <50 ng/dL and <20 ng/dL) from Day 29 to Day 169 for Cohort 3, Time to castration (testosterone level <50 ng/dL and <20 ng/dL), Investigator’s assessment (4-point rating scale) of erythema, swelling, and induration at the injection site immediately after Debio 4228 injection, 2 hours, and 24 hours (Day 2) after Debio 4228 injection, Participants’ self-assessment of pain at the injection site immediately after Debio 4228 injection, 2 hours, and 24 hours (Day 2) after Debio 4228 injection using Numeric Pain Rating Scale (NPRS), Incidence and severity of treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs, adverse events of special interest (AESIs), death, and TEAEs leading to treatment delay, and/or discontinuation, graded according to National Cancer Institute Common Termin | — |
Countries
Belgium, Bulgaria, France, Italy, Lithuania, Poland, Spain
Outcome results
None listed