Phase 2
Completed N=51
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Source: ClinicalTrials.gov NCT02212197 ↗Enrolled (actual)
51
Serious AEs
2.0%
Results posted
Feb 2017
Primary outcomePrimary: Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3 — 6.14; 9.66; 13.6; 5.36 ng/mL
Summary
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3 |
6.14; 9.66; 13.6; 5.36; 11.3; 12.1 | — |
| PRIMARY Apparent Terminal Half-life (t½) for Dose 1 and Dose 3 |
205; 231; 743; 299; 434; 378 | — |
| PRIMARY Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3 |
329; 622; 397; 343; 757; 460 | — |
| SECONDARY Time (Days) to Testosterone Recovery After Dose 3 |
46.2; 52.3; 65 | — |
| SECONDARY Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP) |
443; 321; 350; 20.9; 24.5; 18.1 | — |
| SECONDARY Mean Prostate Specific Antigen (PSA) Concentration |
14.9; 18.8; 14.6; 9; 8.3; 4.6 | — |
Eligibility Criteria
Inclusion Criteria
- Men ≥40 and ≤85 years of age
- Histological or cytological proven adenocarcinoma of the prostate requiring hormone therapy
- Life expectancy over 12 months
- World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1 or 2
- Adequate and stable renal function
- Adequate and stable hepatic function
Exclusion Criteria
- Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction
- Serum Testosterone levels below 150 ng/dL at Screening visit
- Medical or radiological prostate cancer treatments within 2 months prior to the Screening visit
- Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit
- Prior orchiectomy, hypophysectomy, or adrenalectomy
- Prior use of LHRH agonists within 12 months prior to the Screening visit and during the study
Data sourced from ClinicalTrials.gov (NCT02212197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.