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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Day 0-28 and at Day 112-140

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

000008

NCT ID:

NCT01491971

Start Date:

January 2012

Completion Date:

November 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

South Florida Medical ResearchAventura, Florida  33180
Urology Centers Of AlabamaHomewood,, Alabama  35205
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Urology San Antonio Research, PASan Antonio, Texas  78229
Premier Medical Group of the Hudson ValleyPoughkeepsie, New York  12601
Carolina Clinical TrialsConcord, North Carolina  28025
South Orange County Urology ResearchLaguna Hills, California  
San Bernadino Urological AssociationSan Bernadino, California  
Urology Clinic of North TexasDallas, Texas