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)

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT02495233
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gilteritinib — DRUG
    oral
  • Erlotinib — DRUG
    oral

Study Details

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.

Key Dates

First listed
Jul 13, 2015
Start date
Sep 8, 2015
Status verified
Nov 2024
Primary completion
Sep 28, 2016
Completion
Sep 28, 2016

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gilteritinib 120mg + Erlotinib 150mg
    Gilteritinib was administered in combination with erlotinib orally once daily.
  • Experimental: Gilteritinib 80mg+ Erlotinib 150mg
    Gilteritinib was administered in combination with erlotinib orally once daily.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 and Cycle ≥2 (up to 141 days) ]

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