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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491971
• Other study ID #: 000008
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2011
• Last updated: November 18, 2013
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix

Locations

Country	Name	City	State
Canada	Euroscope Inc	Barrie	Ontario
Canada	Bramalea Medical Centre	Brampton	Ontario
Canada	Urology South Shore Research	Greenfield Park	Quebec
Canada	Urology Associates/Urologic Medical Research	Kitchener	Ontario
Canada	Office of Dr. Bernard Goldfarb	North Bay	Ontario
Canada	Pacific Urologic Research	Victoria	British Columbia
United States	South Florida Medical Research	Aventura	Florida
United States	Carolina Clinical Trials	Concord	North Carolina
United States	Urology Clinic of North Texas	Dallas	Texas
United States	Urology Centers of Alabama	Homewood	Alabama
United States	South Orange County Urology Research	Laguna Hills	California
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Urology San Antonio Research, Pa	San Antonio	Texas
United States	San Bernadino Urological Association	San Bernadino	California

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)		Day 0-28 and at Day 112-140	No
Primary	Trough plasma levels (blood sample analysis)	Actual levels prior to dosing	Day 28, 56, 84, 112, 140, 168 and 196	No
Secondary	Proportion of patients with testosterone =0.5 ng/mL		From baseline to Day 196	No
Secondary	Serum levels of testosterone and PSA		From baseline to Day 196	No
Secondary	Percentage change in PSA levels		From baseline to Day 196	No
Secondary	Changes in patient-reported injection site pain (VAS scores over time)	Will compare starting dose to maintenance doses	At 5 minutes and at 60 minutes after each injection	No
Secondary	Proportion of patients without clinically significant pain (VAS score of =10 mm)		60 minutes after each dosing injection	No
Secondary	Incidence and severity of investigator-evaluated injection site reactions		From baseline to Day 196	No
Secondary	Cumulative probabilities of suppressing testosterone to castrate level (=0.5 ng/mL) by visit		From Day 28 onwards (up to Day 196)	No
Secondary	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	No
Secondary	Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs		From baseline to Day 196	No
Secondary	Clinically significant changes in laboratory values		From baseline to Day 196	No
Secondary	Clinically significant changes in ECGs, vital signs, physical examinations, and body weight		From baseline to Day 196	No