Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is
administered as a single agent in a multiple ascending dose escalation phase to investigate
dose level for monotherapy. Part B follows the multiple ascending dose phase, additional
patients with tumors with documented PIK3CA gene mutation will be enrolled to a single dose
expansion phase. Part C is a second dose escalation phase in which post-menopausal patients
with estrogen receptor positive (ER+), HER2 negative breast cancer will receive AZD8835 in
combination with fulvestrant. Part D follows the combination dose escalation phase of the
study, additional postmenopausal patients with ER+/HER2 negative breast cancer with
documented PIK3CA gene mutation will be enrolled to a AZD8835 and fulvestrant combination
dose-expansion phase at maximum tolerated dose or recommended phase II dose.