NL-OMON48773撤回3 期
Randomized multicenter, phase III trial evaluating the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (* 65 years) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen (CABASTY). - CABASTY
ARTIC0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient aged * 65 years with mCRPC previously treated with docetaxel
- •2. Medical or surgical castration with castrate level of testosterone (< 50
- •ng/dl) based on the EAU definition of castrate level of testosterone
- •3. Progressive disease according to PCWG2 (Appendix H)
- •4. Histologically proven prostate carcinoma
- •5. Health status allowing use of chemotherapy: G8 > 14; or G8 score * 14 with
- •geriatric assessment concluding to reversible impairment allowing use of
- •chemotherapy
- •6. ECOG-PS 0, 1 or 2(ECOG-PS 2 should be related to prostate cancer)
- •7. Adequate hematologic, liver and renal functions:
- •a) Neutrophil count *1.5 109/L
- •b) Haemoglobin *10 g/ dL
- •c) Platelet count *100.109/L
- •d) Total bilirubin * 1 the upper limit of normal (ULN)
- •e) Transaminases * 1.5 ULN
- •f) Serum creatinine * 2.0 ULN
- •8. Ongoing LHRH therapy at study entry
- •9. Signed informed consent
排除标准
- •1.History of severe hypersensitivity reaction (.grade 3) to docetaxel
- •2.History of severe hypersensitivity reaction (.grade 3) to polysorbate 80
- •containing drugs
- •3.Uncontrolled severe illness or medical condition (including uncontrolled
- •diabetes mellitus)
- •4.Concurrent or planned treatment with strong inhibitors or strong inducers of
- •cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who
- •are already on these treatments) (see Appendix E)
- •5.ECOG-PS >2 not related to prostate cancer disease
- •6.G8 . 14 with geriatric assessment contra-indicating standard cabazitaxel
- •7.Concomitant vaccination with yellow fever vaccine
- •8.Patient who cannot be regularly followed or cannot answer to quality of life
- •questionnaires because of psychological, social, familial or geographic reasons
- •9.Participation in another clinical trial with any investigational drug within
- •30 days prior to study enrolment
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