Phase I dose-escalation study of S 81694 administered intravenously in adult patients with advanced/metastatic solid tumors

Institut de Recherche Internationales Servier0 个研究点目标入组 39 人开始时间: 2015年6月30日最近更新: 2022年5月30日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35567919/ (added 16/05/2022)

•1. Male or female patients with age = 18 years
•2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumour in patients for whom no effective standard therapy is available or suitable
•3. Elapsed time of 4 weeks or, in absence of toxicity, of 5 half-lives between the completion of the prior antineoplastic therapy including biologic, immunologic or targeted anticancer therapy and S 81694 first administration
•4. Elapsed time of 6 weeks for nitrosoureas or mitomycin C
•5. Resolution (return to baseline) or return to NCI CTCAE Grade = 1 of all acute toxicities due to prior anticancer therapy except alopecia, grade 2 paraesthesia, grade 2 hyper- or hypothyroidism and other non-clinically significant adverse events
•6. ECOG (WHO) performance status 0-1
•7. Patient must use effective contraception

•1. Patients who have undergone treatment with high-dose chemotherapy requiring progenitor cell transplantation
•2. Episode(s) of clinically relevant active bleeding in the past 3 weeks
•3. Known history of haemolytic anaemia (including G6PD deficiency), thrombotic thrombocytopenic purpura (TTP), microangiopathic haemolytic anaemia (MAHA), haemolytic uremic syndrome(HUS)
•4. Clinically significant respiratory or metabolic diseases uncontrolled by medication
•5. Patients with uncontrolled high blood pressure
•6. Presence of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT syndrome)

发起方