Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: leuprolide acetate FluidCrystal® injection depot
* Drug: leuprolide acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAM2032 3.75 mg<br>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. | Drug: leuprolide acetate FluidCrystal® injection depot<br> <br> * Other names: CAM2032;|
| Experimental: CAM2032 7.5 mg<br>Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. | Drug: leuprolide acetate FluidCrystal® injection depot<br> <br> * Other names: CAM2032;|
| Active Comparator: Eligard 7.5 mg<br>Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56. | Drug: leuprolide acetate<br> <br> * Other names: Eligard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 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, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP). | 84 days | 
| Apparent Terminal Half-life (t½) for Dose 1 and Dose 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, t1/2 was derived for Doses 1 and 3 of the IMP. | Days 0-28 and Days 56-84 | 
| Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 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. | Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (Days) to Testosterone Recovery After Dose 3 | The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126. | Days 56-126 | 
| Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP) | The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126. | Days 0-126 | 
| Mean Prostate Specific Antigen (PSA) Concentration | The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126. | Days 0-126 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, leuprolide