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

NCT01491971 | Completed Phase 2 DMC

• 1 other identifier: 000008
• Study Type: interventional
• Target: 76
• Locations: 2 countries
• Sites: 15

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

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

  Day 0-28 and at Day 112-140

• Trough plasma levels (blood sample analysis)

  Actual levels prior to dosing

  Day 28, 56, 84, 112, 140, 168 and 196

Secondary Outcomes (11)

• 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

Study Arms (3)

Degarelix - Cohort 1

EXPERIMENTAL

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Drug: Degarelix

Degarelix - Cohort 2

EXPERIMENTAL

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Drug: Degarelix

Degarelix - Cohort 3

EXPERIMENTAL

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Drug: Degarelix

Interventions

Degarelix DRUG

Degarelix - Cohort 1; Degarelix - Cohort 2; Degarelix - Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (15)

Urology Centers of Alabama

Homewood, Alabama, United States

Location

South Orange County Urology Research

Laguna Hills, California, United States

Location

San Bernadino Urological Association

San Bernadino, California, United States

Location

South Florida Medical Research

Aventura, Florida, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, United States

Location

Carolina Clinical Trials

Concord, North Carolina, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Location

Urology Clinic of North Texas

Dallas, Texas, United States

Location

Urology San Antonio Research, Pa

San Antonio, Texas, United States

Location

Pacific Urologic Research

Victoria, British Columbia, Canada

Location

Euroscope Inc

Barrie, Ontario, Canada

Location

Bramalea Medical Centre

Brampton, Ontario, Canada

Location

Urology Associates/Urologic Medical Research

Kitchener, Ontario, Canada

Location

Office of Dr. Bernard Goldfarb

North Bay, Ontario, Canada

Location

Urology South Shore Research

Greenfield Park, Quebec, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 14, 2011
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 12, 2013

Record last verified: 2013-11

Locations

CA (6); US (9)