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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01252693
First received: December 1, 2010
Last updated: October 30, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 2014 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252693

Locations
United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Texas
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Urology San Antonio Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
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: October 30, 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 October 01, 2014