CTRI/2020/08/026967尚未招募未知
To assess the efficacy of low dose Abiraterone (250 mg (1 tablet) once daily taken along with food) in comparison to the standard dose Abiraterone (1000 mg (4 tablets) taken in fasting state) in patients with Metastatic Castrate Resistant Prostate Cancer.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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.Histologically or cytologically confirmed prostate cancer with progressive disease defined as either: Radiographic progression, PSA Progression OR Evidence of castration resistance defined as disease progression despite a testosterone level ââ?°Â¤ 50 ng/dL (or surgical castration)
- •2.Denosumab or zoledronic acid are allowed
- •3.ECOG 0,1,2
- •4.Patients must have normal hepatic function as defined below- a)Total bilirubin < 1.5 x the upper limit of normal b)AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
排除标准
- •a)Inability to swallow capsules or gastrointestinal malabsorption
- •b)Patients who have taken abiraterone in the hormone sensitive prostate cancer (HSPC) setting
- •c)History of other malignancies with exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or curatively treated solid and hematological tumors with no evidence of disease for ââ?°Â¥ 3 years from enrollment
- •d)Serum K+ less than 3.5 mmol/L
- •e)Uncontrolled intercurrent infection or other uncontrolled medical illness
- •f)Active psychiatric illness which would limit compliance
- •g)New York Heart Association (NYHA) class II, III or IV heart failure
- •a.NYHA Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
- •b.NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20ââ?¬â?100 m). Comfortable only at rest.
- •c.NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
- •h)Concurrent therapy with strong inhibitors or inducers of CYP3A4 Use of an investigational product within the prior 30 days
研究者
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