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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01491971
First received: November 22, 2011
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax) [ Time Frame: Day 0-28 and at Day 112-140 ] [ Designated as safety issue: No ]
  • Trough plasma levels (blood sample analysis) [ Time Frame: Day 28, 56, 84, 112, 140, 168 and 196 ] [ Designated as safety issue: No ]
    Actual levels prior to dosing


Secondary Outcome Measures:
  • Proportion of patients with testosterone ≤0.5 ng/mL [ Time Frame: From baseline to Day 196 ] [ Designated as safety issue: No ]
  • Serum levels of testosterone and PSA [ Time Frame: From baseline to Day 196 ] [ Designated as safety issue: No ]
  • Percentage change in PSA levels [ Time Frame: From baseline to Day 196 ] [ Designated as safety issue: No ]
  • Changes in patient-reported injection site pain (VAS scores over time) [ Time Frame: At 5 minutes and at 60 minutes after each injection ] [ Designated as safety issue: No ]
    Will compare starting dose to maintenance doses

  • Proportion of patients without clinically significant pain (VAS score of ≤10 mm) [ Time Frame: 60 minutes after each dosing injection ] [ Designated as safety issue: No ]
  • Incidence and severity of investigator-evaluated injection site reactions [ Time Frame: From baseline to Day 196 ] [ Designated as safety issue: No ]
  • Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit [ Time Frame: From Day 28 onwards (up to Day 196) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs [ Time Frame: From baseline to Day 196 ] [ Designated as safety issue: No ]
  • Clinically significant changes in laboratory values [ Time Frame: From baseline to Day 196 ] [ Designated as safety issue: No ]
  • Clinically significant changes in ECGs, vital signs, physical examinations, and body weight [ Time Frame: From baseline to Day 196 ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix - Cohort 1
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Drug: Degarelix
Experimental: Degarelix - Cohort 2
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Drug: Degarelix
Experimental: Degarelix - Cohort 3
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Drug: Degarelix

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491971

Locations
United States, Alabama
Urology Centers of Alabama
Homewood, Alabama, United States
United States, California
South Orange County Urology Research
Laguna Hills, California, United States
San Bernadino Urological Association
San Bernadino, California, United States
United States, Florida
South Florida Medical Research
Aventura, Florida, United States
United States, New York
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
United States, North Carolina
Carolina Clinical Trials
Concord, North Carolina, United States
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
United States, Texas
Urology Clinic of North Texas
Dallas, Texas, United States
Urology San Antonio Research, Pa
San Antonio, Texas, United States
Canada, British Columbia
Pacific Urologic Research
Victoria, British Columbia, Canada
Canada, Ontario
Euroscope Inc
Barrie, Ontario, Canada
Bramalea Medical Centre
Brampton, Ontario, Canada
Urology Associates/Urologic Medical Research
Kitchener, Ontario, Canada
Office of Dr. Bernard Goldfarb
North Bay, Ontario, Canada
Canada, Quebec
Urology South Shore Research
Greenfield Park, Quebec, Canada
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01491971     History of Changes
Other Study ID Numbers: 000008
Study First Received: November 22, 2011
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014