A phase Ib, open-label study of oral BGJ398 in combination with oral BYL719 in adult patients with select advanced solid tumors

ovartis Pharma Services AG0 个研究点目标入组 55 人开始时间: 2013年12月20日最近更新: 2016年9月26日

适应症

试验速览

暂无简介。

•Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anticancer therapy exists
•Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
•Measurable disease defined by RECIST v1.1
•ECOG performance status of =2
•other, protocol-defined criteria may apply.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)
•Colorectal cancer (for patients enrolled to expansion part)
•Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose = 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
•Use of medications that increase serum levels of phosphorus and/or calcium
•Inorganic phosphorus outside of normal limits
•Total and ionized serum calcium outside of normal limits
•other, protocol-defined criteria may apply.

发起方