NCT02113813

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

An Open-label, Phase 1 Dose Escalation Study of Oral ASP8273 in Subjects With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is composed of 2 parts: part 1 is the dose escalation phase and part 2 is the recommended Phase 2 dose (RP2D) phase, Food Effect (FE) cohort and Exon 20 cohort.

Conditions

• Non-Small-Cell Lung Cancer (NSCLC)
• Epidermal Growth Factor Receptor Mutations

Interventions

Type	Name	Description
DRUG	naquotinib	oral
DRUG	midazolam	oral

Timeline

• Start date: 2014-04-09
• Primary completion: 2017-07-28
• Completion: 2019-02-11
• First posted: 2014-04-15
• Last updated: 2024-11-14

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study