Clinical Trial to Evaluate the Safety and Effectiveness of GDC-0032 When Given Alongside Tamoxifen
Status:
Suspended
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
This study is designed as a phase 1 dose escalation study followed by a randomised phase II
study. The study will be performed in three different centres: Addenbrooke & Cambridge
university (Cambridge, UK), Netherlands Cancer Institute Amsterdam), and Vall d'Hebron
Hospital (Barcelona, Spain).
Three to six patients will be followed for one completed cycle of therapy (28 days) and
subsequent enrolment of new cohorts will be based on the safety assessment in that first
cycle and the documentation of dose limiting toxicities. To determine the safety and efficacy
of tamoxifen in combination with the isoform selective Pi3K inhibitor GDC-0032 compared with
tamoxifen alone.