NCT00598312已完成3 期
A Phase 3, Open-Label, Multi-Center, Safety And Efficacy Study of Oakwood Laboratories' Leuprolide Acetate For Injectable Suspension 22.5 mg In Patients With Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- The percentage of responders who attain and maintain castrate levels of serum testosterone
研究概览
简要总结
The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer.
详细描述
This study is an open-label, multi-center study in which a minimum of 165 patients will receive one (1) of three (3) lots of Oakwood Laboratories' Leuprolide Acetate for Injectable Suspension 22.5 mg for two cycles. A subset of patients (minimum of 12) will be assigned to each lot (A, B or C) and will have additional blood sampling to characterize leuprolide release kinetics for each dose administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Reads, understands and is able and willing to sign informed consent form
- •Males greater than or equal to age 45
- •Histologically and cytologically documented prostate carcinoma
- •Candidate for initial hormone therapy - inclusive of patients beginning neoadjuvant or intermittent therapy, being treated locally for advanced disease, or patients beginning therapy for failure of prior local therapy
- •Patients who have had prior LHRH therapy in an adjuvant or neoadjuvant setting, providing that the last date of effective therapy was greater than 6 months prior to screening
- •Morning serum testosterone level > 150 ng/dL
- •Standard screening labs within 2x ULN (AST, ALT, bilirubin and serum creatinine)
- •Hemoglobin > 10 g/dL
- •Life expectancy of >1yr.
- •Willing to complete both cycles and all procedures of the study
排除标准
- •Any prior (except for prior LHRH therapy in an adjuvant or neoadjuvant setting) or current definitive therapy for prostate cancer, including chemotherapy, immunotherapy, tumor-vaccines,biological response modifiers, or estrogens
- •Patients who have undergone any prostatic surgery within 4 weeks of Baseline
- •Patients who have undergone orchiectomy, adrenalectomy, or hypophysectomy
- •Patients that are currently hospitalized or require frequent hospitalization
- •Prior resistance to LHRH therapy, either neoadjuvant or adjuvant.
- •Patients with evidence of spinal cord compression, ureteral obstruction or clinically significant bladder outlet obstruction
- •Participation in any investigational drug, biologic, or device study within five half-lives of its physiological action or three months prior to enrollment, whichever was longer
- •Patients anticipated to need concomitant hormonal, anti-androgen, radio-, chemo-, immuno- or surgical therapy for prostate cancer while on study
- •History of recent drug and/or alcohol abuse within 6 months of screening
- •History of HIV, HCV or HBV infection
- •History of hypersensitivity or known allergy to LHRH agonists or antagonists
- •Concurrent use of daily corticosteroids or other agents known to modify serum androgen within 12 weeks of screening visit
- •Patients on other anti-androgens such as flutamide, nilutamide or bicalutamide
- •History of other cancer with the exception of non-metastatic basal or squamous cell carcinoma of the skin
- •Patients receiving any type of 5-alpha reductase inhibitor such as Proscar, Propecia, or Avodart within the past 3 months
- •Patients who have experienced a myocardial infarction, unstable or uncontrolled cardiovascular disease or a coronary vascular procedure within 6 months of Baseline
- •Patients who have experienced venous thrombosis within 6 months of Baseline
- •Patients with other serious intercurrent illness(es) or disease(s)that might interfere with, or put them at additional risk for, their ability to receive the treatment outlined in the protocol
- •Patients who have a history of the following: Immunization within 4 weeks of Baseline; Flu shots within 2 weeks of Baseline; Donation or receipt of blood or blood products within 2 months of Baseline; Anaphylaxis
- •Patients who have received Oakwood's leuprolide acetate formulation previously.
结局指标
主要结局
The percentage of responders who attain and maintain castrate levels of serum testosterone
时间窗: From Day 28 to Day 168.
次要结局
- Safety as shown through laboratory parameters(Day 0 - Day 168)
- Leuprolide serum profiles following administration study drug product.(Day 0 - Day 168)
- Safety as shown through reported adverse events(Day 0 -168)
研究者
研究点 (2)
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