NCT01546623已完成3 期
A Phase 3, Multi-center, Randomized, Open-label, Parallel-group, Comparative Study of TAP-144-SR (3M) to Evaluate Hormone Dynamics, Pharmacokinetics, Safety and Efficacy of TAP-144-SR (6M) 22.5 mg Subcutaneous Injection for 48 Weeks in Prostate Cancer Patients Previously Treated With Hormonal Therapy
Takeda0 个研究点目标入组 160 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- The Rate of Suppression of Serum Testosterone to Castrate Level
研究概览
简要总结
The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously treated with hormonal therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The participant has histopathologically confirmed prostate cancer in Japanese.
- •The participant has prostate cancer in the clinical stages of T1b-T4, N-any and M-any by TNM classification on clinical diagnosis at the time of diagnosis.
- •The participant has ECOG performance status of grades 0, 1, or 2 at screening.
- •The participant with PSA level which has not increased 25 % or greater and 2 ng/mL or more from the nadir at the measurement points 4 weeks or longer apart within the screening period of 12 weeks.
- •Patients who receive the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) at screening
- •Patients who have received the marketed products, TAP-144-SR (1M) and TAP-144-SR (3M), for 24-96 weeks in total at the scheduled starting date of the study drug, but not including administration period treated as neoadjuvant therapy for prostatectomy and/or radiation therapy
- •Patients who have continued the nonsteroidal antiandrogen for longer than 12 weeks at the scheduled starting date of the study drug, if a nonsteroidal antiandrogen is concomitantly administered
- •The participant with a serum testosterone level at screening < 100ng/dL
- •The participant meets the following criteria of renal, bone-marrow and hepatic functions on the laboratory test results at screening:
- •（1） Renal function: serum creatinine level< 1.5 times the upper limit of normal (ULN) （2） Bone-marrow function: white blood count ≥ 3,500/ mm3, platelet count ≥ 100,000/L, hemoglobin ≥ 10.0g/dL （3） Hepatic function: AST(GOT), ALT(GPT), ALP and total bilirubin ≤ 2.5 times the ULN
- •The participant's life expectancy is at least 24 months at informed consent.
排除标准
- •The participant has active multiple primary cancers, (synchronous multiple primary cancer or metachronous multiple primary cancer with the disease-free survival ≤ 5 years)
- •The participant has received surgical castration.
- •The participant has ever received LHRH agonists other than commercially available 1-month or 3-month depot of leuprolide acetate.
- •The participant has ever received LHRH antagonists.
- •Patients who have previously received estrogen preparations or corticosteroids for prostate cancer
- •Patients who have previously received chemotherapy for prostate cancer
- •Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) or the marketed products for 1 month (LEUPLIN FOR INJECTION 3.75 and KIT 3.75) as an adjuvant therapy after prostatectomy and/or radiotherapy
- •Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) for intermittent androgen deprivation therapy
- •Patients who received the following drugs within 24 weeks (168 days) after starting the study drug: Steroidal antiandrogens, type II 5α-reductase inhibitors
- •The participant received any of the following within 16 weeks (112 days) prior to study enrollment:
- •（1） Radiotherapy. As for I-125 brachytherapy, within 35 weeks (245 days) prior to study enrollment.
- •（2） Prostatectomy （3） Experimental therapy including high-intensity focused ultrasound therapy (HIFU), immunotherapy, and gene therapy
- •Patients who received the following drugs within 4 weeks (28 days) before starting the study drug: Testosterones, ketoconazole（except for external preparations）, spironolactone, corticosteroids (excluding their inhalants and external preparations), and Chinese medicines and dietary supplements containing saw palmetto
- •Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at screening
- •The participant has a history of hypersensitivity to synthetic LHRH, LHRH derivative or any component of the study drug.
- •The participant has central nervous system metastasis which requires treatment or which is symptomatic.
- •The participant already has a history or has a complication or may have renal disorder caused by spinal cord compression or ureteric obstruction.
- •The participant has a history of serious drug allergic reaction/hypersensitivity
- •The participant has a history of, or has been diagnosed with thromboembolism including myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism, or cardiac failure
研究组 & 干预措施
TAP-144-SR(3M)
Active Comparator
TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
干预措施: TAP-144-SR(3M) (Drug)
TAP-144-SR(6M)
Experimental
TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
干预措施: TAP-144-SR(6M) (Drug)
结局指标
主要结局
The Rate of Suppression of Serum Testosterone to Castrate Level
时间窗: From the start of study drug administration through Week 48
Comparison of the proportion of patients maintained at castration level (≤100 ng/dL)
次要结局
- Time Course of Changes in Serum Testosterone(From baseline to Week 48)
- Time Course of Changes in Serum Luteinizing Hormone (LH)(From baseline to Week 48)
- Time Course of Change Rate in Serum PSA (FAS)(From baseline to Week 48)
- Soft Tissue Response(At week 48)
- Serum Unchanged TAP-144 Level(From baseline to Week 48)
- Percentage of Participants With Progression by PSA (FAS)(From baseline to Week 48)
- Bone Lesion Response(At Week 48)
- The Maximum Rate of Change in PSA Suppression (FAS)(From baseline to Week 48)
- 12-lead ECG(At 1 hour, week 24, and week 48 after administration)
- Time Course of Changes in Serum Follicle-stimulating Hormone (FSH)(From baseline to Week 48)
研究者
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