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.
Description: Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that started after administration of the study drugs and occurred within 30 days of the last dose of the study drugs. If a participant experienced an event both during the preinvestigational period and during the investigational period, the event was considered a TEAE only if it worsened in severity.Measure: Number of Participants With Adverse Events Time: From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Description: All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.Measure: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib Time: Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4
Description: ORR was defined as Objective Response Rate (ORR) was the proportion of patients whose best overall response was complete response (CR) or partial response (PR) per RECIST version 1.1. Only patients with measurable disease at baseline were to be included in the analysis of ORR.Measure: Objective Response Rate (ORR) in Phase 1b Time: End of treatment (approximately 4 months)
There are 2 SNPs
- Participant had a documented exon 19 deletion or exon 21 L858R EGFR activating mutation. --- L858R ---
- Participant's baseline tumor specimen (obtained after participant developed resistance to EGFR TKI therapy) is T790M negative. --- T790M ---
- Participant received any agent with antitumor activity (other than an EGFR inhibitor, including a T790M inhibitor) including chemotherapy, radiotherapy, immunotherapy, within 14 days prior to the first dose of study drug (palliative radiotherapy is allowed). --- T790M ---