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Completed

NCT Number: NCT02212197

Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Docrates Cancer Center, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

leuprolide acetate FluidCrystal® injection depot

Drug

Other names: CAM2032

Leuprolide Acetate

Drug

Other names: Eligard

Primary outcomes

  1. Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3

    Time frame: 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).

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

    Time frame: 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.

  3. 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)

    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.

Secondary outcomes

  1. Time (Days) to Testosterone Recovery After Dose 3

    Time frame: Days 56-126

    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.

  2. Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)

    Time frame: Days 0-126

    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.

  3. Mean Prostate Specific Antigen (PSA) Concentration

    Time frame: Days 0-126

    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.

Sponsors and collaborators

Lead sponsor

Camurus AB

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 8, 2014
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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