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

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Trial Identification

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

Official Title: 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

Study ID: NCT02192697

Conditions

Non-small Cell Lung Cancer

Interventions

ASP8273

Study Description

Brief 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