Phase I dose-escalation study of oral administration of MET Tyrosine Kinase Inhibitor S 49076 in patients with advanced solid tumours

Institut de Recherches Internationales Servier (France)0 个研究点目标入组 110 人开始时间: 2013年8月2日最近更新: 2018年5月21日

适应症

试验速览

•1. Male or female patient aged 18 years or older
•2. Advanced solid tumour that has relapsed or is refractory to standard therapy or for which no effective standard therapy is available
•3. Ability to swallow oral capsule(s)
•4. Estimated life expectancy of more than 12 weeks
•5. ECOG performance status less than or equal to 1
•6. Adequate haematological, renal and hepatic functions

•1. Major surgery within 4 weeks prior to the first day of the study drug administration
•2. Chemotherapy within 3 weeks prior to the first day of the study drug administration (6 weeks in the case of treatment with nitroso-ureas)
•3. Any other prior therapy involving an agent directed to the solid tumours within five times of the half-life of said agent but not less than 3 weeks prior to the first day of study drug administration
•4. Hormonal therapy directed to the solid tumours within 2 weeks prior to the first day of study drug administration (6 weeks in the case of treatment with bicalutamide), except in the case of LHRH agonist therapy for prostate cancer which is permitted.
•5. Radiotherapy within 4 weeks prior to the first day of the study drug administration (within 1 week in the case of palliative radiotherapy at localised lesions)
•6. Cumulative radiation therapy involving more than 25% of the total bone marrow
•7. Concomitant uncontrolled infection or severe systemic disease (at the discretion of the investigator)
•8. Known organ dysfunction which would either compromise the patient's safety or interfere with the evaluation of the study drug safety
•9. Patients with impaired cardiac function

发起方

Institut de Recherches Internationales Servier (France)