Subjects With NSCLC With an EGFR Activating Mutation Clinical Trial
Official title:
An Open-label, Multicenter, Rollover Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study
The purpose of the study is to evaluate long-term safety and tolerability of continuous treatment with ASP8273 in subjects who are participating in an Astellas-sponsored ASP8273 study which has completed, at a minimum, the primary analysis or have completed the individual study evaluation period and for whom the investigator feels the subject may have potential to continue to derive clinical benefit from treatment with ASP8273.
This is a multicenter, rollover study for subjects with non-small cell lung cancer (NSCLC)
with an epidermal growth factor receptor (EGFR) activating mutation who are currently
participating in studies evaluating ASP8273.
Subjects should sign the informed consent at cycle 1 day 1 visit. The assessments from the
last treatment visit from the parent study can be utilized for the cycle 1 day 1 visit.
Either local or central laboratories may be utilized for the cycle 1 day 1 visit if
assessments are used from the last treatment visit of the parent study. The subject will then
receive ASP8273 study drug for the rollover study and return all ASP8273 study drug from the
parent study. Subjects will continue on to subsequent 28-day cycles until 1 of the
discontinuation criteria are met. Upon enrollment, subjects with fewer than 6 cycles of study
drug dosing in the parent study will return to the clinic on day 1 of each cycle up to cycle
5. After cycle 5, these subjects can switch to day 1 of every other odd cycle for clinic
visits. Subjects with 6 or more cycles of study drug dosing upon enrollment into the rollover
study will return to the clinic on day 1 of every other odd cycle (e.g., cycles 3, 5, etc.).
Imaging methods and frequency will be performed per standard of care.
An end of treatment study visit will be conducted 30 days after the last dose of study
medication.
;