CTRI/2011/04/001673已完成4 期
A Phase IV, Single Arm, Multi-Centric, Non-Comparative, Study to Evaluate Efficacy, Safety And Tolerability Of Bicalutamide In Advanced and/or Metastatic Prostate Cancer - NI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 36
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.A potential subject willing to give written informed consent on his own or LAR/Impartial witness in case of an illiterate subject
- •2.Subjects entering the study should be greater than or equal to 18 Years and less than 80 Years of age.
- •3.Subjects entering the study should be clinically and histopathologically confirmed as diagnosed with advanced / metastatic prostate cancer.
- •4.Subjects participating in the study should agree to use effective contraception, in order to avoid female partner pregnancy.
- •5.Subjects participating in the study should have a baseline Serum PSA titre of greater than or equal to 10 ng/ml.
- •6.Subjects who have undergone prior radiotherapy and/or surgery can be included in the study provided, the radiotherapy and/or surgery has occurred at least 4 weeks prior to the initiation of treatment with the study drug.
- •7.Subjects participating in the study should have adequately controlled diabetes or cardiovascular disease, if suffering from any.
- •8.Subjects entering the study should have Hematology Profile specifications as follows: Hemoglobin (Hb) greater than 9.0 gm / dl, Platelete greater than or equal to 1, 00,000/ cumm.
- •9.Subjects entering the study should have clinical chemistry specifications as follows: Hepatic Profile (Bilirubin, Total Bilirubin less than or equal to 1.5 (times ULN), Alanine Transaminase (ALT) less than or equal to 2.5 times ULN, Aspartate Transaminase (AST) less than or equal to 2.5 times ULN, and Renal Functions (Serum Creatinine less than or equal to 1.5 times (ULN).
- •10.ECOG Performance Status of less than or equal to 2.
- •11.Subjects participating in the study should have a life expectancy of at least 6 months as per the investigators discretion.
- •12.Subjects who are surgically castrated will be included in the study.
- •13.Potential subjects should be willing to comply with the study procedures.
排除标准
- •1.Subjects with any clinically significant lab test and co-morbidity including any concurrent disease that could affect the patients? safety, as per the Investigator?s discretion.
- •2.Subjects with known Central Nervous System (CNS) metastasis, having a clinically stable disease of at less than 8 weeks prior to the administration of the study drug (A patient with known CNS metastasis and having a clinically stable disease of 8 weeks or more can be included in the study.)
- •3.Subjects under concurrent therapy with any other non-protocol anti-cancer therapy, including hormonal therapy or any other systemic anti-cancer therapy.
- •4.Subjects under treatment for ANY Acute Urinary Tract Infection (UTI) or any other active clinically significant systemic infections.
- •5.Subjects who are known to be hypersensitive to the study drug or to any of the excipients.
- •6.Subjects who have been on the investigational drug within 30 days, prior to screening.
研究者
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