drugset / Trial / 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)
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-09-08
- Primary completion
- 2016-09-28
- Completion
- 2016-09-28
Outcome
Outcome not reported
Stopped: “Study terminated due to adverse events related to the combination therapy”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Subject | Gilteritinib | Small molecule | 80 mg | Oral |
| Subject | Gilteritinib | Small molecule | 120 mg | Oral |