Status:
COMPLETED
International,Multi-Center,Open Label,Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot in Men With Prostate Cancer
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to assess the safety and efficacy of a monthly regimen of ozarelix administered subcutaneously (SC) versus Goserelin depot administered subcutaneously in men with Prostate Can...
Detailed Description
Prospective study subjects will undergo screening procedures. Approximately 214 eligible patients will enter the study. Patients will be randomized in a 1:1 ratio to one of two treatment arms (Ozareli...
Eligibility Criteria
Inclusion
- Patients, aged 18 years or older, with histologically proven prostate cancer of any stages, for whom endocrine treatment is indicated.
- Screening testosterone \> 1.5 ng/ml
- Life expectancy of at least 12 months
- ECOG score of ≤ 2
- Patient has reviewed and signed Informed consent form
- Patient understands and is willing to comply with the protocol
Exclusion
- Any hormone therapy prior to study entrance
- Any patient at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge
- History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema
- History of hypersensitivity towards any components of the study drug
- History or presence of any other malignancy other than treated squamous cell /basal cell carcinoma of the skin within the last five years
- ECG at screening showing QTc \>450 ms, or family history of long QT syndrome
- Abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial
- • - Has a clinically significant medical condition (other than prostate cancer) including but not limited to: renal, hematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease, alcohol or drug abuse or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator
- Taking Class IA or Class III antiarrhythmic medication
- Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
- Has received investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of this trial
- Has previously participated in any Ozarelix trials
- Is part of an ongoing trial.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT01252693
Start Date
November 1 2010
End Date
May 1 2015
Last Update
October 5 2021
Active Locations (3)
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1
The Urology Center of Colorado
Denver, Colorado, United States, 80211
2
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
3
Urology San Antonio Research
San Antonio, Texas, United States, 78229