EUCTR2013-000809-23-SK进行中（未招募）1 期
A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC)
AB Science0 个研究点目标入组 581 人开始时间: 2014年4月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 581
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.1.Patient aged = 18 years old, with histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone < 0.5ng/ml) with one of the following criteria:
- •-Pre-treated with abiraterone with progressed disease documented, OR
- •-with indication for initiating docetaxel administration (e.g., widespread visceral disease or rapidly progressive disease).
- •2.Patient with evidence of progressive metastatic disease. Disease progression at trial enrolment is based on progression in at least one variable described in Table 5.
- •3.Patient with ECOG = 1
- •4.Patient with adequate organ function:
- •Absolute neutrophil count (ANC) = 1.5 x 10ç/L
- •Haemoglobin = 10 g/dL
- •Platelets (PTL) = 75 x 109/L
- •AST/ALT = 3x ULN (=5 x ULN in case of liver metastases)
- •Gamma GT =2.5 x ULN (=5 x ULN in case of liver metastases)
- •Bilirubin = 1.5x ULN
- •Normal creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- •Albumin > 1 x LLN
- •Proteinuria < 30 mg/dL (1+) on the dipstick; in case of proteinuria = 1+ on the dipstick, 24 hours proteinuria must be = 1.5g/24h
- •5.Patient with life expectancy > 6 months
- •6.Patient with BMI > 18 and patient weight > 40 kg
- •7.Male patients must use medically acceptable methods of contraception if your female partner is pregnant, from the time of the first administration of the study drug until three months following administration of the last dose of study drug. Acceptable methods include:
- •If you have undergone surgical sterilization (vasectomy with documentation of azoospermia) a condom should also be used.
- •Male patients must use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. The acceptable methods of contraception are as follows:
- •Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- •Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository);
- •Your female partner uses oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository);
- •Medically prescribed topically-applied transdermal contraceptive patch and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository);
- •Your female partner has undergone documented tubal ligation (female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film
排除标准
- •1.Patient who has been previously treated with chemotherapy.
- •2.Patient with bone marrow irradiation > 40% within 12 months before baseline
- •3.Patient treated for a cancer other than prostate cancer within 3 years before enrollment, with the exception of basal cell carcinoma (and pTa or pT1)
- •4.Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
- •5.Patient presenting with cardiac disorders defined by at least one of the following conditions:
- •Patient with recent cardiac history (within 6 months) of:
- •oAcute coronary syndrome
- •oAcute heart failure (class III or IV of the NYHA classification)
- •oSignificant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- •Patient with cardiac failure class III or IV of the NYHA classification
- •Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •Syncope without known aetiology within 3 months
- •Uncontrolled severe hypertension, according to the judgement of the investigator, or symptomatic hypertension
研究者
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