Prostate Cancer
Conditions
Brief summary
The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.
Interventions
DRUGDebio 4228
Administered as IM injection.
Sponsors
Debiopharm International SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant with histologically confirmed diagnosis of prostate cancer, with one of the following: 1. Newly diagnosed androgen-sensitive locally advanced or metastatic disease; or 2. Localized disease not suitable for local primary intervention with curative intent. 2. Participant judged by the Study Investigator to be candidate for continuous androgen deprivation therapy (ADT). 3. Baseline morning serum testosterone levels \>150 ng/dL at screening visit. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Life expectancy of at least 6 months. 6. Adequate bone marrow, hepatic, and renal function at the screening visit. \[Note: Other protocol and subprotocol-defined criteria apply\]
Exclusion criteria
1. Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and \<6 months treatment-free interval before start of screening. 2. Participant requires combination with androgen deprivation therapy with the exception of enzalutamide. 3. History of bilateral orchiectomy, adrenalectomy, or hypophysectomy. 4. Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer. 5. Abnormal cardiovascular function or diabetes. 6. Use of exogenous testosterone within 6 months before the start of screening. 7. Major surgery within 4 weeks before the start of screening. 8. Cancer disease within the last two years except for prostate cancer and some skin cancers. \[Note: Other protocol and subprotocol-defined criteria apply\]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) of Debio 4228 | Cohorts 1 and 2: Predose and at multiple time points post-dose up to Day 169; Cohort 3: Predose and at multiple time points post-dose up to Day 169 |
| Area Under the Concentration-time Curve of Debio 4228 Over 12 weeks (AUC84d) | Cohorts 1 and 2: Predose and at multiple time points post-dose up to Day 84; Cohort 3: Predose and at multiple time points post-dose up to Day 169 |
| Plasma Concentration of Debio 4228 at Week 12 (C84d) | Cohorts 1 and 2: Post-dose on Day 84; Cohort 3: Post-dose on Days 84 and 168 |
| Serum Concentration of Testosterone | Cohorts 1 and 2: Predose and at multiple time points post-dose from Days 1 to 85; Cohort 3: Predose and at multiple time points post-dose from Days 1 to 169 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants who Achieved and Maintained a Testosterone Castration (Testosterone Level of <50 [Nanograms per Deciliter] ng/dL and <20 ng/dL) | Cohorts 1, 2, and 3: Days 29 to 85 |
| Number of Participants who Maintained a Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL) | Cohort 3: Days 29 to 169 |
| Time to Achieve Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL) | Cohorts 1 and 2: Day 1 up to Day 85; Cohort 3: Day 1 up to Day 169 |
| Number of Participants who Experience Local Reactions Categorized as Erythema, Swelling, and Induration at the Injection Site | Cohorts 1 and 2: Immediately, at 2 and 24 hours post-injection on Day 1; Cohort 3: Immediately, at 2 and 24 hours post-injection on Days 1 and 85 |
| Number of Participants who Experience Pain at Injection Site | Cohorts 1 and 2: Immediately, at 2 and 24 hours post-injection on Day 1; Cohort 3: Immediately, at 2 and 24 hours post-injection on Days 1 and 85 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity | Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197 |
| Number of Participants With Related TEAEs, Serious TEAEs, Adverse Events of Special Interest (AESIs), TEAEs Leading to Treatment Delay, and/or Discontinuation, and Death | Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197 |
| Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, and Electrocardiogram (ECG) Parameters | Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197 |
| Percent Change From Baseline in Serum Prostate-Specific Antigen (PSA) Over Time | Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169 |
| Change From Baseline of Serum Luteinizing Hormone (LH) Over Time | Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169 |
| Change From Baseline in Serum Follicle-Stimulating Hormone (FSH) Over Time | Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169 |
Countries
France, Spain, United States
Outcome results
None listed