NCT02495233

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)

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Gilteritinib	oral
DRUG	Erlotinib	oral

Timeline

• Start date: 2015-09-08
• Primary completion: 2016-09-28
• Completion: 2016-09-28
• First posted: 2015-07-13
• Last updated: 2024-11-27
• Results posted: 2019-02-15

Locations

4 sites across 1 country: Japan