An Phase II, Open label,Randomized, Multicentric,Clinical Trial of Mycobacterium w in combination with Docetaxel versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer

Cadila Pharmaceuticals ltd0 个研究点目标入组 176 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Â§:Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease.
•Â§:Disease progression during antiandrogen therapy, having surgical or medical castration status.
•Â§:Karnofsky Performance Status 50-100
•Â§:Normal cardiac function.
•Â§:Life expectancy atleast 24 weeks
•Â§:Laboratory criteria for eligibility will include
•Â§:A neutrophil count of at least 1500 per cubic millimeter,
•Â§:A hemoglobin level of at least 9 gm%,
•Â§:A platelet count of at least 100,000 per cubic millimeter,
•Â§:A total bilirubin not greater than 1.5 times the upper limit of the normal range for each institution,
•Â§:Serum creatinine levels not more than 1.5 times the upper limit of the normal range.
•Â§:Written informed consent.

•§:Prior treatment with cytotoxic agents or radioisotopes.
•§:Estrogen use for at least three months.
•§:History of another cancer within the preceding five years (except basal or squamous-cell skin cancer).
•§:Brain or leptomeningeal metastases.
•§:Symptomatic peripheral neuropathy of grade 2 or higher.
•§:Uncontrolled intercurrent illness that would limit compliance with study requirements

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