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

Camurus AB51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

leuprolide acetate FluidCrystal® injection depotDRUG

leuprolide acetateDRUG

Eligibility

Sex: MALEMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (7)

Docrates Cancer Center

Helsinki, Finland

University Hospital of Helsinki, Department of Urology

Helsinki, Finland

Tampere University Hospital, Department of Urology

Tampere, Finland

University Hospital of Turku, Department of Urology

Turku, Finland

Outcomes

Primary Outcomes

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).

Time frame: 84 days

Apparent Terminal Half-life (t½) for Dose 1 and Dose 3

Time frame: 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

Time frame: Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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