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drugset / Trial / NCT02113813

A Dose Escalation Study of ASP8273 in Subjects With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations

NCT02113813 ↗

Phase 1 Completed 133 enrolled Astellas Pharma Global Development, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and tolerability of ASP8273 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). This study will also determine the pharmacokinetics (PK) of ASP8273, evaluate the potential inhibition of CYP3A4 by ASP8273 and the antitumor activity of ASP8273 as well as determine the effect of food on the bioavailability of ASP8273.

Timeline

Start
2014-04-09
Primary completion
2017-07-28
Completion
2019-02-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule — Oral
Subject naquotinib Small molecule — Oral

Indications

non-small cell lung carcinoma