NCT02192697

An Open Study of ASP8273 in Patients With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations

An Open-label Study of the Oral Administration of ASP8273 in Patients With Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Mutations

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Purpose of the study is to determine the following in patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations. * the safety and tolerability of ASP8273. * the pharmacokinetics (PK) of ASP8273. * the antitumor activity of ASP8273.

Detailed description

This study consists of Phase I and Phase II. The objectives of Phase I are to determine the following in patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations. * safety and tolerability of ASP8273. * the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of ASP8273 based on the dose limiting toxicity (DLT) profile. * pharmacokinetics (PK) of ASP8273. * antitumor activity of ASP8273. The objectives of Phase II are to determine the following at the RP2D of ASP8273 in patients with NSCLC harboring EGFR mutation. * efficacy of ASP8273 * safety of ASP8273 * PK of ASP8273

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ASP8273	Oral administration

Timeline

• Start date: 2014-01-23
• Primary completion: 2016-01-15
• Completion: 2017-06-14
• First posted: 2014-07-17
• Last updated: 2024-11-14

Locations

14 sites across 3 countries: Japan, South Korea, Taiwan