5549W-14 Astellas Oral ASP8273 in Subjects With NSCLC who have EGFR

CRC 14035: 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

Type of Study
Cancer (Oncology) - Lung
Swedish Cancer Institute
Short Description
Purpose:  The purpose of this study is to assess the safety of ASP8273 and to determine a safe dose of the study drug in patients with advanced Non-Small Cell Lung Cancer (NSCLC). This study also wants to investigate the effect of other drugs on ASP8273.
Open to Enrollment
Principal Investigator
Howard (Jack) West, M.D.
Eligibility Notes
  • Aged 18 Years or older
  • Non-child bearing potential or able to follow birth control requirements
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1
  • Life expectancy ≥ 12 weeks
  • Laboratory criteria as:

    • Neutrophil count ≥ 1,500/mm3
    • Platelet count ≥ 7.5 x 104 /mm3
    • Hemoglobin ≥ 9.0 g/dL
    • Lymphocyte count ≥ 500/mm3
    • Serum creatinine < 1.5 x institutional Upper Limit of Normal (ULN) or an estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation
    • Total bilirubin < 1.5 x ULN (except for subjects with documented Gilbert's syndrome)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x ULN
  • Dose escalation subjects: Epidermal Growth Factor Receptor (EGFR) activating mutation by local testing: exon 18 G719X, exon 19 deletion, exon 21 L861Q, exon 21 L858R or exon L861Q; and received prior treatment with EGFR Tyrosine Kinase Inhibitor (TKI)
  • Response expansion/RP2D expansion subjects: disease progression on prior EGFR TKI; no anticancer treatment subsequent to EGFR TKI; activating mutation as above AND T790M mutation; tumor sample subsequent to EGFR TKI is available for central testing; at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086