EUCTR2013-000491-14-SK进行中（未招募）1 期
A prospective, multicenter, open-label, centrally allocated, active-controlled, phase 2 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced/metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third line.
AB Science0 个研究点目标入组 80 人开始时间: 2015年7月1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
- 80
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.Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer (including primary peritoneal and primary fallopian tube cancer) either:
- •a.first line platinum-refractory ovarian cancer (progression during first-line platinum-based chemotherapy)
- •b.first line platinum-resistant ovarian cancer (relapsing within 6 months after the end of first-line chemotherapy);
- •c.candidate to third line treatment (refractory or resistant to 2nd line platinum-based therapy or patients who progressed after other type of chemotherapy in 2nd line)
- •2.Patient has recovered of all acute toxic side effects of prior therapy or surgical procedures to grade = 1 Common Toxicity Criteria for Adverse Event (CTCAE v4.03), except for the laboratory values
- •3.Patient has at least one target lesion that can be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST).
- •4.ECOG Performance status = 2
- •5.Patient with adequate organ function
- •a.Absolute neutrophils count (ANC) = 1.5 x 109/L
- •b.Haemoglobin = 10 g/dl
- •c.Platelets (PLT) = 75 x 109/L
- •d.AST and ALT = 3 x ULN (= 5 x ULN in case of liver metastases)
- •e.Gamma GT = 2.5 x ULN (= 5 x ULN in case of liver metastases)
- •f.Bilirubin = 1.5x ULN (= 3xULN in case of liver metastases)
- •g.Normal Creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- •h.Albuminaemia > 1 x LLN
- •i.Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
- •6.Patient with life expectancy > 3 months
- •7.Patient weight > 40 kg and BMI > 18 Kg/m2
- •8.Female patient = 18 years
- •9.Patient with nutritional risk index (NRI) = 83.5, i.e. with no or moderate malnutrition; NRI is calculated as follows: NRI = 1.519 x serum albumin level + 0.417 x (current weight / basic weight) x 100
- •- serum albumin in g/L
- •- basic weight calculation with Lorentz formula for ideal BW for women: (height - 100) - ((height - 150)/2)
- •10.Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use a highly effective method of contraception and an acceptable method of contraception by her male partner during the study and for 3 months (6 months for gemcitabine) 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 usu
排除标准
- •A patient must not be enrolled if she fulfils one of the following exclusion criteria:
- •1.Patient intolerant to gemcitabine
- •2.Patient who has not recovered from any significant treatment toxicities prior to baseline (=Grade 2)
- •3.Patient presenting with cardiac disorders defined by at least one of the following conditions:
- •a)Patient with recent cardiac history (within 6 months) of:
- •-Acute coronary syndrome
- •-Acute heart failure (class III or IV of the NYHA classification)
- •-Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- •b)Patient with cardiac failure class III or IV of the NYHA classification
- •c)Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •d)Syncope without known aetiology within 3 months
- •e)Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
- •4.Pregnant or nursing female patient
- •5.Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
- •6.Patient treated for a cancer other than epithelial ovarian cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
- •7.Patient with history of poor compliance or 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
- •1.Patient who had any major surgery within 4 weeks before baseline
- •2.Patient treated with any investigational agent within 4 weeks prior baseline
- •3.Patient who had systemic chemotherapy within 4 weeks before baseline
- •4.Patient who had radiotherapy within 4 weeks before baseline
研究者
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