drugset / Trial / NCT03082300

A Study of ASP8273 in Subjects With Non-small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations

NCT03082300

Phase 1 Terminated 3 enrolled Astellas Pharma Global Development, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

The objective of this study is to evaluate the bioequivalence of a tablet formulation versus a capsule formulation of ASP8273 following a single dose under fasted condition in subjects with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. The study will also evaluate the safety and tolerability of a tablet formulation as a single dose and a capsule formulation as a single and multiple dose of ASP8273 in subjects with NSCLC harboring EGFR mutations.

Timeline

Start
2017-03-24
Primary completion
2017-05-12
Completion
2017-06-19

Drugs

EvaluationDrugModalityDoseRoute
Subject naquotinib Small molecule Oral