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
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Purpose
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 Cancer. This is an international, multi-center, randomized, open label 84 days study. Men who are at least 18 years of age or older, with histologically proven prostate cancer of all stages, in whom endocrine treatment is indicated will be eligible for study entry.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Ozarelix Drug: Goserelin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot (Zoladex®) in Men With Prostate Cancer |
- To assess the percentage of patients with testosterone <=0.5ng/mL. [ Time Frame: From Day 28 through Day 84, in men receiving Ozarelix versus Goserelin ] [ Designated as safety issue: Yes ]
- Percentage change in Prostate-Specific Antigen level [ Time Frame: From baseline to day 14 and day 28 ] [ Designated as safety issue: Yes ]
Additional secondary outcomes:
- Percentage of patients with testosterone level <=0.5 ng/mL at day 3
- Median time to reach 50% suppression of baseline Prostate Specific Antigen level
- Percentage of patients with testosterone surge ("hormone escape") during the first two weeks of treatment
- To assess the safety of Ozarelix SC monthly dosing compared to Goserelin depot SC monthly dosing in men with Prostate Cancer
| Estimated Enrollment: | 214 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ozarelix |
Drug: Ozarelix
Ozarelix Loading dose of 130 mg SC at randomization will be followed by maintenance dosing of 65 mg SC at day 8, 28 and 56.
|
| Active Comparator: Goserelin |
Drug: Goserelin
Goserelin depot 3.6 mg at randomization will be followed by 3.6 mg SC on days 28 and 56.
|
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 (Ozarelix or Goserelin). Eligible patients randomized to the ozarelix group will receive two SC injections of ozarelix 65 mg in the abdomen on Day 1 (left lower quadrant, LLQ and right lower quadrant, RLQ), followed by a SC injection of 65 mg of Ozarelix (abdomen LLQ) on day 8 and will receive 2 additional SC injections of Ozarelix on days 28 and 56 (alternating injection sites). Eligible patients randomized to Goserelin will receive one 3.6 mg SC injection in the abdomen (LLQ or RLQ), followed by a 3.6 mg SC injection on Days 28 and 56 (alternating injection sites). Ozarelix will be reconstituted and administered as a 65 mg injection. Patients will receive two Ozarelix 65 mg subcutaneous injections (SC) on Day 1, and one 65 mg SC injection on day 8, followed by one 65 mg injection on days 28 and 56. The patients will receive one Goserelin 3.6 mg SC injection at baseline, Day 28 and Day 56.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| Contact: Pankaj Sharma, MD | 416-245-2719 | pankaj.sharma@sppirx.com |
| United States, Colorado | |
| The Urology Center of Colorado | Recruiting |
| Denver, Colorado, United States, 80211 | |
| Contact: Robin Dorsey 303-762-7155 rdorsey@tucc.com | |
| Principal Investigator: Lawrence Karsh, MD | |
| United States, Texas | |
| Urology Clinics of North Texas | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Principal Investigator: James Cochran, MD | |
| Urology San Antonio Research | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Joe Perez 210-617-4116 | |
| Principal Investigator: Daniel Saltzstein, MD | |
| India | |
| Vardhaman Mahavir Medical College And Safdarjung Hospital | Recruiting |
| New Delhi, Delhi, India | |
| Contact: Mahendra Joshi +91-9818217692 joshmeinmj68@yahoo.co.in | |
| Principal Investigator: Nayan K Mohanty, MD | |
| Samved Hospital | Not yet recruiting |
| Ahmedabab, Gujrat, India | |
| Contact: Nisha Joshi, MD +91-9724813522 drjoshi82@yahoo.com | |
| Principal Investigator: Janak Desai, MD | |
| HCG Bangalore Institute Of Ongology | Not yet recruiting |
| Bengaluru, Karnataka, India, 560 027 | |
| Contact: Subarna Roy Acharya +91-9886150015 subarna@triesta.com | |
| Principal Investigator: S K Raghunath, MD | |
| Topiwala National Medical College and B.Y.L. Nair Charitable Hospital | Not yet recruiting |
| Mumbai, Maharastra, India | |
| Contact: Surekha, MD '+91-22-23002638 nairurology@gmail.com | |
| Principal Investigator: Hemant Pathak, MD | |
| Noble Hospital | Not yet recruiting |
| Pune, Maharastra, India | |
| Contact: Vijeta Kadam, MD +91-9960603097 vijeta.kadam@gmail.com | |
| Principal Investigator: Rajendra Shimpi, MD | |
| Christian Medical College and Hospital | Not yet recruiting |
| Ludhiana, Punjab, India, 141 008 | |
| Contact: Shafiq Ahmad, MD +91-9257347339 dr.shafiqahmad@rediffmail.com | |
| Principal Investigator: Kim Mammen, MD | |
| Fortis Escorts Hospital | Not yet recruiting |
| Jaipur, Rajasthan, India | |
| Contact: Mukesh Sharma +91-9351791799 mksharma1961@yahoo.com | |
| Principal Investigator: Madan Bansal, MD | |
| Saway Maan Singh Medical College and Hospital | Not yet recruiting |
| Jaipur, Rajasthan, India | |
| Contact: Nachiket Vyas, MD +91-9413957314 nachiketvyas@hotmail.com | |
| Principal Investigator: Rajeev Mathur, MD | |
| Khushi Maternity & Surgical Center | Not yet recruiting |
| Ghaziabad, UP, India | |
| Contact: Noopur Sharma, MD +91-9810394608 dr.sharma.noopur@gmail.com | |
| Principal Investigator: Sanjay Garg, MD | |
| Uro-Health Research Center | Not yet recruiting |
| Lucknow, UP, India | |
| Contact: Shuabul Haq Safvi, MD +91-9450022615 drshsafvi@gmail.com | |
| Principal Investigator: Divakar Dalela, MD | |
| Chhatrapati Shahuji Maharaj Medical University | Not yet recruiting |
| Lucknow, UP, India | |
| Contact: Shuabul Haq Safvi, MD +91-9450022615 drshsafvi@gmail.com | |
| Principal Investigator: Apul Goel, MD | |
| Ajit Surgical and maternity center | Not yet recruiting |
| Noida, UP, India | |
| Contact: Subod Prasad +91-9818053880 | |
| Principal Investigator: Ajit Saxena, MD | |
| Woodland Medical Centre | Not yet recruiting |
| Kolkatta, West Bengal, India | |
| Contact: Ruchira Sarkar +91-9830613608 sarkarruchira@yahoo.co.in | |
| Principal Investigator: Kalyan Sarkar, MD | |
| Study Director: | Pankaj Sharma, MD | Spectrum Pharmaceuticals, Inc |
More Information
No publications provided
| Responsible Party: | Spectrum Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT01252693 History of Changes |
| Other Study ID Numbers: | SPI-153-10-1 |
| Study First Received: | December 1, 2010 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Goserelin Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013