drugset / Trial / NCT02248090

AZD9496 First Time in Patients Ascending Dose Study

NCT02248090

Phase 1 Completed 45 enrolled AstraZeneca
NaSingle-groupOpen-labelTreatment

Summary

This is a phase 1 open label multicentre study of AZD9496 administered orally in patients with advanced ER+ HER2 negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose. In addition, expansion cohort(s) at potential therapeutic dose(s) in patients with or without ESR1 mutations will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of AZD9496

Timeline

Start
2014-10-22
Primary completion
2017-01-31
Completion
2019-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD9496 Small molecule Oral