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临床试验/JPRN-jRCT2080221721
JPRN-jRCT2080221721未知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

TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 160 人开始时间: 2012年2月28日最近更新:
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适应症

试验速览

阶段
3 期
发起方
入组人数
160
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 <= 85age old（—）
性别
Male

入选标准

  • •1. The participant has histopathologically confirmed prostate cancer in Japanese.
  • •2. The participant has prostate cancer in the clinical stages of T1b-T4, anyN and anyM by TNM classification on clinical diagnosis at the time of diagnosis.
  • •3. The participant has ECOG performance status of grades 0, 1, or 2 at screening.
  • •4. 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.
  • •5. Patients who receive the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) at screening
  • •6. 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
  • •7. 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
  • •8. The participant with a serum testosterone level at screening < 100ng/dL
  • •9. 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
  • •10. The participant's life expectancy is at least 24 months at informed consent.

排除标准

  • •1. The participant has active multiple primary cancers, (synchronous multiple primary cancer or metachronous multiple primary cancer with the disease-free survival =< 5 years)
  • •2. The participant has received surgical castration.
  • •3. The participant has ever received LHRH agonists other than commercially available 1-month or 3-month depot of leuprolide acetate.
  • •4. The participant has ever received LHRH antagonists.
  • •5. Patients who have previously received estrogen preparations or corticosteroids for prostate cancer
  • •6. Patients who have previously received chemotherapy for prostate cancer
  • •7. 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
  • •8. Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) for intermittent androgen deprivation therapy
  • •9. Patients who received the following drugs within 24 weeks (168 days) after starting the study
  • •drug: Steroidal antiandrogens, type II 5alpha-reductase inhibitors
  • •10. 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
  • •11. 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
  • •12. Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at screening
  • •13. The participant has a history of hypersensitivity to synthetic LHRH, LHRH derivative or any component of the study drug.
  • •14. The participant has central nervous system metastasis which requires treatment or which is symptomatic.
  • •15. The participant already has a history or has a complication or may have renal disorder caused by spinal cord compression or ureteric obstruction.
  • •16. The participant has a history of serious drug allergic reaction/hypersensitivity
  • •17. 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

研究者

发起方
TAKEDA PHARMACEUTICAL COMPANY LTD.

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