A Phase I Study of ASP8273 in Patients with Non-Small Cell Lung Cancer and EGFR Mutations

Protocol
14-128
Full Title
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
Phase
I
Purpose

Many non-small cell lung cancers (NSCLC) contain a mutant form of a protein called epidermal growth factor receptor (EGFR) and are treated with drugs that target this protein. Erlotinib or afatinib are the typical first treatments, but the average response is only a year.

ASP8273 is a drug designed to block mutated EGFR permanently. Laboratory studies have shown that ASP8273 prevented the growth of tumor cells that expressed mutated EGFR and was effective after erlotinib or afatinib had stopped working.

The purpose of this study is to find the highest dose of ASP8273 that can be given safely in patients with NSCLC that expresses mutant EGFR and has grown despite prior therapy that targeted this protein. ASP8273 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic or inoperable NSCLC that expresses mutant EGFR.
  • Patients’ cancers must have grown despite receiving treatment with a tyrosine kinase inhibitor such as erlotinib, gefitinib, afatinib, dacomitinib, or neratinib.
  • At least 1-2 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-888-4274.

Disease(s)
Lung Cancer, Non-Small Cell
Locations