A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
Status:
Completed
Trial end date:
2020-04-16
Target enrollment:
Participant gender:
Summary
This is a first-in-man trial, in which BYL719 will be administered to adult patients with
advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease
has progressed despite standard therapy or for whom no standard therapy exists. A combination
of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally
advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The
single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion
cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type
PIK3CA gene