EUCTR2013-000809-23-GB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). - Phase 3 Masitinib/Placebo + Docetaxel in Metastatic Prostate Cancer V1
AB Science0 个研究点目标入组 580 人开始时间: 2014年8月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 580
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
- 性别
- Male
入选标准
- •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).
- •-*If surgical castration is done than there will be no requirement to perform testosterone test.
- •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 4
- •3. Patient with ECOG = 1
- •4. Patient with adequate organ function:
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- Haemoglobin = 10 g/dL
- •- Platelets (PTL) = 75 x 109/L
- •- AST and 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 (= 3 x ULN in case of liver metastasis)
- •- Normal creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- •- Albuminaemia > 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 kg/m2 and weight > 40 kg
- •7.Contraception
- •?Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an acceptable method of contraception by his female partner during the study and for 3 months after the last treatment intake or who agrees to use an acceptable method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake.
- •?Highly effective methods of contraception include:
- •-Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
- •-Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
- •-Intrauterine device (IUD)
- •-Intrauterine hormone-releasing system (IUS)
- •-Bilateral tubal occlusion
- •-Vasectomized male (azoospermia assessed medically)
- •-Sexual abstinence (Its reliability should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
- •?Acceptable methods of contraception include:
- •-Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- •-Male or female condom with or without spermicide
- •-Cap, diaphragm, or sponge with spermicide
- •8. Patient able and willing to comply with study procedures as per protocol
- •9. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent.
- •10. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of
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 enrolment, 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:
- •o Acute coronary syndrome
- •o Acute heart failure (class III or IV of the NYHA classification)
- •o Significant 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 (atrioventricular 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
- •6. Patient with an history of poor compliance or an history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
- •7. Patient under treatment with any anti-tumour therapy (any radiotherapy, chemotherapy, biologic or anti-androgen therapy except GnRH/LHRH analogs)
- •Known hypersensitivity to masitinib or to any of the excipients
- •Patients with any investigational agent within 4 weeks prior to baseline
- •Patients with an active infection requiring antibiotics within 14 days prior to baseline
- •Four weeks prior to baseline for anti-androgens (example. bicalutamide) and 5-alpha reductase inhibitors
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