CTRI/2021/07/034710已完成未知
A Phase 3 Pilot Study to evaluate the Efficacy of Leuprolide Acetate 11.25 mg (3-Month Depot Injection) of Bharat Serums and Vaccines Limited, India and Lucrin® (Leuprolide acetate) 11.25 mg depot injection administered subcutaneously in male patients with advanced prostate cancer
Bharat Serums and Vaccines ltd0 个研究点目标入组 8 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 8
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
入选标准
- •1. Male subjects aged above 18 years
- •2. Histologically or cytologically confirmed adenocarcinoma of the prostate at stage T1b-4, Nany, Many in subjects, who would benefit from a GnRH agonist
- •3. Baseline Testosterone of >1.50 ng/mL or >150 ng/dL
- •4. For subjects with radical prostatectomy, an increase of 0.2 ng/mL or 20 ng/dL in PSA from previous test on two consecutive tests. For subjects with prostate irradiation a rise of greater than or equal to 2.0 ng/mL or 200 ng/dL PSA above the nadir
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix 2)
- •6. Life expectancy of at least 6 months from screening
- •7. Adequate organ and immune system function as indicated by the following laboratory values, obtained <= 14 days prior to dosing
- •Absolute Neutrophil Count more than equal to 1500/mm3
- •-Hb more than equal to 9.0 g/dL
- •-Platelets more than equal to100,000/mm3
- •-Serum Creatinine less than equal to 1.6 mg/dL
- •-Total Bilirubin less than equal to1.5 mg/dL or less than equal to 2 mg/dL (for liver mets)
- •-AST (SGOT) less than equal to 2.5 Ã? ULN or less than equal to 5 Ã? ULN (for liver mets)
- •-ALT (SGPT) less than equal to2.5 Ã? ULN or less than equal to 5 Ã? ULN (for liver mets)
- •8.Willing to participate and sign the informed consent as per regulatory requirements
排除标准
- •1. Evidence of brain metastases
- •2. Evidence of spinal cord compression
- •3. Evidence of urinary tract obstruction
- •4. Received prostate cancer therapies like immunotherapy external radiotherapy, brachytherapy, chemotherapy or biological response modifiers within two months of enrolment
- •5. Undergone any prostate surgery (e.g. transurethral resection of the prostate (TURP), radical prostatectomy)
- •6. Under the effects of any other hormonal therapy, including anti-androgens for treatment of prostate cancer
- •7. Received leuprolide previously
- •8. Had an orchiectomy, adrenalectomy or hypophysectomy
- •9. Had used any investigational drug, biologic, or device within five half-lives of its physiological action or three months
- •10. Anticipated to need concomitant hormonal, anti-androgen, radiotherapy, chemotherapy, immunotherapy or surgical therapy for prostate cancer throughout the duration of the study
- •11. Used over-the-counter (OTC) or alternative medical therapies which has an estrogenic or anti-androgenic effect (e.g., Glycyrrhiza, Dehydroepiandrosterone (DHEA), PC-SPES, saw palmetto)
- •12. Used finasteride, dutasteride, estrogens, megestrol acetate, anti-androgens (Bicalutamide, Flutamide, or Cyproterone), and ketoconazole
- •13. Co-existent malignancy or a history of malignancy, with the exception of basal and/or squamous cell carcinomas of the skin.
- •14. Uncontrolled congestive heart failure within 6 months before baseline
- •15. Experienced a myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft surgery
- •16. Significant symptomatic cardiovascular disease
- •17. Experienced venous thrombosis
- •18. Uncontrolled hypertension (more than equal to 160/100 mmHg) or symptomatic hypotension
- •19. Insulin-dependent diabetes mellitus
- •20. History of drug abuse
- •21. Serious intercurrent illnesses or diseases that might interfere with the treatment outlined in the protocol.
- •22. Receiving anticoagulants or antiplatelet medications. Receiving warfarin-derivative anticoagulants with International normalized ratio (INR) outside therapeutic range
- •23. Known hypersensitivity to GnRH, GnRH agonists or any excipients of Leuprolide
- •24. Positive test for HIV, HCV, HbsAg at Screening
- •25. History of:
- •a. Immunization
- •b. Flu shots
- •c. Donation or receipt of blood or blood products
- •d. Anaphylaxis
- •e. Skin disease
- •f. Dermatographism
研究者
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