EUCTR2011-001790-41-FR进行中（未招募）不适用
A prospective, multicenter, randomised, open-label, active-controlled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor resistant to imatinib
AB Science0 个研究点目标入组 210 人开始时间: 2011年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- All
入选标准
- •1. Patient with histological proven non-operable locally advanced or metastatic GIST
- •2. Patient with measurable tumor lesions with longest diameter = 20 mm using conventional techniques or = 10 mm with spiral CT scan according RECIST criteria
- •3. Patient with C-kit (CD117) positive tumour detected immuno-histochemically
- •4. Patients resistant to imatinib at dose of 400 (for all countries) or 600 mg/day (only for US). Resistance is defined as a RECIST 1.1 disease progression under imatinib treatment
- •5. Patient with ECOG = 2
- •6. Patient with adequate organ functions:
- •Absolute neutrophils count (ANC) = 1.5 x 109/L
- •Haemoglobin = 10 g/dL
- •Platelets (PTL) = 75 x 109/L
- •AST/ALT = 2.5x ULN (= 5 x ULN in case of liver metastases)
- •Gamma GT < 3 x ULN (< 5 x ULN in case of liver metastases)
- •Bilirubin = 1.5x ULN (= 3xULN in case of liver metastases)
- •Creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- •Albumin > 1 x LLN
- •Urea = 2 x ULN
- •Proteinuria < 30 mg/mL (1+) on the dipstick. If proteinuria is = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
- •7. Patient with life expectancy > 6 months
- •8. Male or female patient, age >18 years
- •9. Patient with a BMI > 18 kg/m² and weighing at least 40kg
- •10. Male and female patient of child bearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two 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.
- •11. Patient able and willing to comply with study procedures as per protocol
- •12. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- •13. Patient affiliated to a social security regimen (for France only) and/or covered by insurance reimbursing sunitinib
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
- •2. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
- •3. Patient presenting with cardiac disorders defined by at least one of the following conditions:
- •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)
- •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 judgment of the investigator, or symptomatic hypertension
- •4. 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
- •5. Pregnant, or nursing female patient
- •Previous treatment
- •6. Patient previously treated with a dose of imatinib >600mg (only for US) or >400mg (outside of the US)
- •7. Patient intolerant to imatinib
- •8. Patients non resistant to imatinib
- •9. Previous treatment with sunitinib or kinase inhibitor other than imatinib
- •Wash-out
- •10. Treatment with any investigational agent within 4 weeks prior to baseline
- •11. Previous imatinib treatment should be permanently discontinued within 4 days prior randomisation and patient should have recovered from potential toxicity related to imatinib
研究者
相似试验
进行中（未招募）
不适用
This study aims to compare the efficienty and safety of masitinib at a dose of 12 mg/kg/dag to those of a standard treatment for GIST: sunitinib (Sutent) at a dose of 50 mg/day for 4 consecutive weeks followed by 2 weeks without medication. Masitinib and sunitinib will be administred untill disease progression in patients with GIST resitant to imatinib (Glivec)stromal gastrointestinal cancer (GIST)MedDRA version: 18.0Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864EUCTR2011-001790-41-BEAB Science208
进行中（未招募）
1 期
A prospective, multicenter, randomised, open-label, active-controlled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imatinibGastrointestinal stromal tumor after progression with imatinibMedDRA version: 17.0Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864EUCTR2011-001790-41-ITAB Science208
进行中（未招募）
1 期
This study aims to compare the efficiency and safety of masitinib at a dose of 12 mg/kg/dag to those of a standard treatment for GIST: sunitinib (Sudent) at a dose of 50 mg/day for 4 consecutive weeks followed by weeks without medication. Masitinib and sunitinib will be administred untill disease progression in patients with GIST after receiving imatinib (Glivec)Stromal gastrointestinal tumor (GIST)MedDRA version: 17.0 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor System Organ Class: 100000004864EUCTR2011-001790-41-GRAB Science208
进行中（未招募）
不适用
Study to compare the safety and efficacy of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imatinib.EUCTR2011-001790-41-GBAB Science350
招募中
3 期
A prospective, multicenter, randomised, open-label, active controlled, 2 parallel groups, phase 3 study to compare the efficay and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imitinibgastro-intestinal stomal tumor (GIST)1001799010017991NL-OMON44774AB Science30