CTRI/2014/02/004382已完成4 期
Multicentre, single arm, open label, non controlled Phase IV clinical trial to evaluate safety of Cabazitaxel (Jevtana) in Combination with oral Prednisone (or prednisolone) for the Treatment of Patients with Metastatic Hormone Refractory Prostate Cancer previously treated with a docetaxel-containing regimen.
Sanofi Synthelabo India Ltd0 个研究点目标入组 9 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
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
- •Metastatic hormone refractory prostate cancer previously treated with a
- •docetaxel-containing regimen
- •Disease Progression during or after docetaxel-containing regimen for mHRPC
- •Surgical or medical castration
- •Patient is >= 18 years and <= 75 years of age
- •This is not exhaustive list.
排除标准
- •Prior radiotherapy to >= 40% of bone marrow
- •Previous treatment with cabazitaxel (Jevtana)
- •Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4
- •weeks prior to enrollment
- •Active grade >=2 peripheral neuropathy
- •Active grade >=2 stomatitis
- •Active infection requiring systemic antibiotic or anti-fungal medication
- •Active cancer (other than mHRPC) including prior malignancy from which the
- •patient has been disease-free for <=5 years
- •This is not exhaustive list.
研究者
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