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

Ferring Pharmaceuticals15 sites in 2 countries76 target enrollmentJanuary 2012

ConditionsProstate Cancer

InterventionsDegarelix

DrugsDegarelix

Overview

Phase: Phase 2
Intervention: Degarelix
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Enrollment: 76
Locations: 15
Primary Endpoint: Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

November 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

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

Arms & Interventions

Degarelix - Cohort 3

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Intervention: Degarelix

Degarelix - Cohort 2

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Intervention: Degarelix

Degarelix - Cohort 1

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Intervention: Degarelix

Outcomes

Primary Outcomes

Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)

Time Frame: Day 0-28 and at Day 112-140

Trough plasma levels (blood sample analysis)

Time Frame: Day 28, 56, 84, 112, 140, 168 and 196

Actual levels prior to dosing

Secondary Outcomes

Proportion of patients with testosterone ≤0.5 ng/mL(From baseline to Day 196)
Serum levels of testosterone and PSA(From baseline to Day 196)
Percentage change in PSA levels(From baseline to Day 196)
Changes in patient-reported injection site pain (VAS scores over time)(At 5 minutes and at 60 minutes after each injection)
Proportion of patients without clinically significant pain (VAS score of ≤10 mm)(60 minutes after each dosing injection)
Incidence and severity of investigator-evaluated injection site reactions(From baseline to Day 196)
Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit(From Day 28 onwards (up to Day 196))
Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)(From Day 28 to Day 364)
Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs(From baseline to Day 196)
Clinically significant changes in laboratory values(From baseline to Day 196)
Clinically significant changes in ECGs, vital signs, physical examinations, and body weight(From baseline to Day 196)