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.
No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
oral
oral
Site JP81004
Fukuoka Minami-ku, Fukuoka, Japan
Site JP81005
Osakasayama, Osaka, Japan
Site JP81003
Suntogun Nagaizumicho,Shizuoka, Japan
Site JP81002
Tokyo, Japan
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 and Cycle ≥2 (up to 141 days)
Number of Participants With Adverse Events
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.
Time frame: From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Maximum Concentration (Cmax) for Gilteritinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.
Time frame: Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4
AUC24 of Erlotinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
Cmax of Erlotinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
Tmax of Erlotinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
Ctrough of Erlotinib
Time frame: Day 8, 15, 22, 28 of cycle 1
Objective Response Rate (ORR) in Phase 1b
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.
Time frame: End of treatment (approximately 4 months)
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