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

March 15, 2017 updated by: Camurus AB

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Docrates Cancer Center
      • Helsinki, Finland
        • University Hospital of Helsinki, Department of Urology
      • Tampere, Finland
        • Tampere University Hospital, Department of Urology
      • Turku, Finland
        • University Hospital of Turku, Department of Urology
  • Hungary
      • Budapest, Hungary
        • Semmelweis University Hospital Department of Urology
      • Budapest, Hungary
        • Szent Imre Teaching Hospital
      • Debrecen, Hungary
        • University of Debrecen, Medical Health Sciences Center, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Eligard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
84 days
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.
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)
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
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.
Days 56-126
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.
Days 0-126
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.
Days 0-126

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Camurus AB

Investigators

  • Principal Investigator: Teuvo Tammela, Prof, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (ESTIMATE)

August 8, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-12-460

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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