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Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer (IM1)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Degarelix
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated
  • Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan

  • Has a PSA level meeting one of these criteria:

    1. For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
    2. For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of ≥0.2 ng/mL from the previous test on two consecutive measurements
    3. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir
  • Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as >150 ng/dL
  • Has an Eastern Cooperative Oncology Group score of ≤2
  • Has a life expectancy of at least one year

Exclusion Criteria:

  • Has had previous or is currently under hormonal management of prostate cancer
  • Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period
  • Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
  • Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms)
  • Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome)
  • Has a previous history or presence of another malignancy, other than prostate
  • Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle
  • Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial

Sites / Locations

  • Urology Centers of Alabama
  • South Orange County Urology Research
  • San Bernadino Urological Association
  • South Florida Medical Research
  • Premier Medical Group of the Hudson Valley
  • Carolina Clinical Trials
  • Carolina Urologic Research Center
  • Urology Clinic of North Texas
  • Urology San Antonio Research, Pa
  • Pacific Urologic Research
  • Euroscope Inc
  • Bramalea Medical Centre
  • Urology Associates/Urologic Medical Research
  • Office of Dr. Bernard Goldfarb
  • Urology South Shore Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Degarelix - Cohort 1

Degarelix - Cohort 2

Degarelix - Cohort 3

Arm Description

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Outcomes

Primary Outcome Measures

Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
Trough plasma levels (blood sample analysis)
Actual levels prior to dosing

Secondary Outcome Measures

Proportion of patients with testosterone ≤0.5 ng/mL
Serum levels of testosterone and PSA
Percentage change in PSA levels
Changes in patient-reported injection site pain (VAS scores over time)
Will compare starting dose to maintenance doses
Proportion of patients without clinically significant pain (VAS score of ≤10 mm)
Incidence and severity of investigator-evaluated injection site reactions
Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit
Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)
Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs
Clinically significant changes in laboratory values
Clinically significant changes in ECGs, vital signs, physical examinations, and body weight

Full Information

First Posted
November 22, 2011
Last Updated
November 18, 2013
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01491971
Brief Title
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
Acronym
IM1
Official Title
Open-label, Multi-centre, Parallel Group Dose-Escalation Trial Assessing the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix - Cohort 1
Arm Type
Experimental
Arm Description
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Arm Title
Degarelix - Cohort 2
Arm Type
Experimental
Arm Description
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Arm Title
Degarelix - Cohort 3
Arm Type
Experimental
Arm Description
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Intervention Type
Drug
Intervention Name(s)
Degarelix
Primary Outcome Measure Information:
Title
Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
Time Frame
Day 0-28 and at Day 112-140
Title
Trough plasma levels (blood sample analysis)
Description
Actual levels prior to dosing
Time Frame
Day 28, 56, 84, 112, 140, 168 and 196
Secondary Outcome Measure Information:
Title
Proportion of patients with testosterone ≤0.5 ng/mL
Time Frame
From baseline to Day 196
Title
Serum levels of testosterone and PSA
Time Frame
From baseline to Day 196
Title
Percentage change in PSA levels
Time Frame
From baseline to Day 196
Title
Changes in patient-reported injection site pain (VAS scores over time)
Description
Will compare starting dose to maintenance doses
Time Frame
At 5 minutes and at 60 minutes after each injection
Title
Proportion of patients without clinically significant pain (VAS score of ≤10 mm)
Time Frame
60 minutes after each dosing injection
Title
Incidence and severity of investigator-evaluated injection site reactions
Time Frame
From baseline to Day 196
Title
Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit
Time Frame
From Day 28 onwards (up to Day 196)
Title
Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)
Time Frame
From Day 28 to Day 364
Title
Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs
Time Frame
From baseline to Day 196
Title
Clinically significant changes in laboratory values
Time Frame
From baseline to Day 196
Title
Clinically significant changes in ECGs, vital signs, physical examinations, and body weight
Time Frame
From baseline to Day 196

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan Has a PSA level meeting one of these criteria: For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL. For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of ≥0.2 ng/mL from the previous test on two consecutive measurements For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as >150 ng/dL Has an Eastern Cooperative Oncology Group score of ≤2 Has a life expectancy of at least one year Exclusion Criteria: Has had previous or is currently under hormonal management of prostate cancer Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms) Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome) Has a previous history or presence of another malignancy, other than prostate Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
Country
United States
Facility Name
South Orange County Urology Research
City
Laguna Hills
State/Province
California
Country
United States
Facility Name
San Bernadino Urological Association
City
San Bernadino
State/Province
California
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Carolina Clinical Trials
City
Concord
State/Province
North Carolina
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Urology Clinic of North Texas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Urology San Antonio Research, Pa
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pacific Urologic Research
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Euroscope Inc
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Bramalea Medical Centre
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Urology Associates/Urologic Medical Research
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
Office of Dr. Bernard Goldfarb
City
North Bay
State/Province
Ontario
Country
Canada
Facility Name
Urology South Shore Research
City
Greenfield Park
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer

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