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

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ClinicalTrials.gov Identifier: NCT02212197
Recruitment Status : Completed
First Posted : August 8, 2014
Results First Posted : February 6, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Camurus AB

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: leuprolide acetate FluidCrystal® injection depot Drug: leuprolide acetate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: CAM2032 3.75 mg
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
Other Name: CAM2032

Experimental: CAM2032 7.5 mg
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
Other Name: CAM2032

Active Comparator: Eligard 7.5 mg
Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.
Drug: leuprolide acetate
Other Name: Eligard




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212197


Locations
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Finland
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
Hungary
Semmelweis University Hospital Department of Urology
Budapest, Hungary
Szent Imre Teaching Hospital
Budapest, Hungary
University of Debrecen, Medical Health Sciences Center, Department of Urology
Debrecen, Hungary
Sponsors and Collaborators
Camurus AB
Investigators
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Principal Investigator: Teuvo Tammela, Prof Tampere University Hospital

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Responsible Party: Camurus AB
ClinicalTrials.gov Identifier: NCT02212197     History of Changes
Other Study ID Numbers: HS-12-460
First Posted: August 8, 2014    Key Record Dates
Results First Posted: February 6, 2017
Last Update Posted: April 25, 2017
Last Verified: March 2017
Keywords provided by Camurus AB:
prostate cancer
leuprolide
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents