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2012年3月

适应症Prostate Cancer

干预措施TAP-144-SR(3M)TAP-144-SR(6M)

相关药物TAP-144-SR(6M)TAP-144-SR(3M)

概览

阶段: 3 期
干预措施: TAP-144-SR(3M)
疾病 / 适应症: Prostate Cancer
发起方: Takeda
入组人数: 160
主要终点: The Rate of Suppression of Serum Testosterone to Castrate Level
状态: 已完成
最后更新: 10年前

概览研究者入排标准研究组 & 干预措施结局指标相似试验

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.

注册库

clinicaltrials.gov

开始日期

2012年3月

结束日期

2014年4月

最后更新

10年前

研究类型

Interventional

研究设计

Parallel

性别

Male

研究者

发起方

Takeda

责任方

Sponsor

入排标准

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

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:

研究组 & 干预措施

TAP-144-SR(3M)

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)

TAP-144-SR(6M)

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)

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)