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A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 (Leuprolide Acetate FluidCrystal® Injection Depot Once Monthly) After Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients With Prostate Cancer
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.
Details
| Lead sponsor | Camurus AB |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 51 |
| Start date | 2014-09 |
| Completion | 2016-03 |
Conditions
- Prostate Cancer
Interventions
- leuprolide acetate FluidCrystal® injection depot
- leuprolide acetate
Primary outcomes
- Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3 — 84 days
Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP). - Apparent Terminal Half-life (t½) for Dose 1 and Dose 3 — Days 0-28 and Days 56-84
Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP. - Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3 — Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)
Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.
Countries
Finland, Hungary