The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
Official Title: A Phase 1b/2 Study of ASP2215 in Combination With Erlotinib in Subjects With EGFR Activating Mutation-Positive (EGFRm+) Advanced NSCLC Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
Study ID: NCT02495233
Brief Summary: The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. The purpose of the Phase 2 part of the study was to evaluate the objective response rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.
Detailed Description: No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Site JP81004, Fukuoka Minami-ku, Fukuoka, , Japan
Site JP81005, Osakasayama, Osaka, , Japan
Site JP81003, Suntogun Nagaizumicho,Shizuoka, , Japan
Site JP81002, Tokyo, , Japan
Name: Senior Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR