NCT03042013

A Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study

An Open-label, Multicenter, Rollover Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Subjects With NSCLC With an EGFR Activating Mutation

Interventions

Type	Name	Description
DRUG	ASP8273	Oral

Timeline

• Start date: 2017-02-28
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2017-02-03
• Last updated: 2017-07-11

Regulatory

• FDA-regulated drug study