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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)

Terminated Phase 1, PHASE2 Results posted Last updated 27 November 2024
What this trial tests

Phase 1, PHASE2 trial testing Gilteritinib in Non-Small-Cell Lung Cancer in 10 participants. Terminated before completion.

Timeline
8 September 2015
Primary endpoint
28 September 2016
28 September 2016

Quick facts

Lead sponsorAstellas Pharma Global Development, Inc.
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment10
Start date8 September 2015
Primary completion28 September 2016
Estimated completion28 September 2016
Sites4 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

18 and older, any sex, with Non-Small-Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose Limiting Toxicities (DLTs) Primary · Cycle 1 and Cycle ≥2 (up to 141 days)
Cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg2
Gilteritinib 80mg+ Erlotinib 150mg2
Cycle ≥2
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg0
Gilteritinib 80mg+ Erlotinib 150mg1
Number of Participants With Adverse Events Primary · From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)

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.

Any TEAEs
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg3
Gilteritinib 80mg+ Erlotinib 150mg7
Drug-related TEAEs
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg3
Gilteritinib 80mg+ Erlotinib 150mg7
TEAEs leading to death
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg0
Gilteritinib 80mg+ Erlotinib 150mg0
Serious TEAEs
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg2
Gilteritinib 80mg+ Erlotinib 150mg3
Drug-related serious TEAEs
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg2
Gilteritinib 80mg+ Erlotinib 150mg2
TEAEs leading to withdrawal of treatment
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg2
Gilteritinib 80mg+ Erlotinib 150mg2
Drug-related TEAEs leading to withdrawal of treat.
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg2
Gilteritinib 80mg+ Erlotinib 150mg2
Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib Secondary · 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Cycle 1 Day 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg2950± 1128
Gilteritinib 80mg+ Erlotinib 150mg1885± 685.6
Cycle 1 Day 28
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg12203± NA
Gilteritinib 80mg+ Erlotinib 150mg8342± 3023
Maximum Concentration (Cmax) for Gilteritinib Secondary · 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Cycle 1 Day 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg210.3± 107.4
Gilteritinib 80mg+ Erlotinib 150mg119± 47.65
Cycle 1 Day 28
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg637± NA
Gilteritinib 80mg+ Erlotinib 150mg408.3± 136.6
Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib Secondary · 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Cycle 1 Day 1,
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg3.961± 0.08221
Gilteritinib 80mg+ Erlotinib 150mg3.762± 0.8109
Cycle 1 Day 28
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg2.00± NA
Gilteritinib 80mg+ Erlotinib 150mg4.594± 1.044
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib Secondary · Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4

All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.

Predose on Day 1 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg0± 0
Gilteritinib 80mg+ Erlotinib 150mg0± 0
Predose on Day 3 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg112± 21.7
Gilteritinib 80mg+ Erlotinib 150mg110.2± 46.51
Predose on Day 8 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg261.3± 31.66
Gilteritinib 80mg+ Erlotinib 150mg282.9± 136.7
Predose on Day 15 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg491.7± 430.5
Gilteritinib 80mg+ Erlotinib 150mg397± 208.9
Predose on Day 22 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg466.3± 128.2
Gilteritinib 80mg+ Erlotinib 150mg414.8± 186.1
Predose on Day 28 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg430± NA
Gilteritinib 80mg+ Erlotinib 150mg241.3± 114.4
Predose on Day 1 of cycle 3
GroupValue95% CI
Gilteritinib 80mg+ Erlotinib 150mg161± 38.18
Predose on Day 1 of cycle 4
GroupValue95% CI
Gilteritinib 80mg+ Erlotinib 150mg236± 104.7
AUC24 of Erlotinib Secondary · 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg34580± NA
Gilteritinib 80mg+ Erlotinib 150mg54055± 22962
Cmax of Erlotinib Secondary · 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg3050± NA
Gilteritinib 80mg+ Erlotinib 150mg3160± 314.3
Tmax of Erlotinib Secondary · 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg2.00± NA
Gilteritinib 80mg+ Erlotinib 150mg2.633± 1.185
Ctrough of Erlotinib Secondary · Day 8, 15, 22, 28 of cycle 1
Predose of Day 8 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg1004± 758.7
Gilteritinib 80mg+ Erlotinib 150mg1827± 1392
Predose of Day 15 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg1427± 1596
Gilteritinib 80mg+ Erlotinib 150mg2098± 1637
Predose of Day 22 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg942.7± 116
Gilteritinib 80mg+ Erlotinib 150mg1999± 1285
Predose of Day 28 of cycle 1
GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg909± NA
Gilteritinib 80mg+ Erlotinib 150mg1368± 1255
Objective Response Rate (ORR) in Phase 1b Secondary · End of treatment (approximately 4 months)

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.

GroupValue95% CI
Gilteritinib 120mg + Erlotinib 150mg0
Gilteritinib 80mg+ Erlotinib 150mg0

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gilteritinib 120mg + Erlotinib 150mg
Serious: 2/3 (67%)
Deaths: 0/3
Gilteritinib 80mg+ Erlotinib 150mg
Serious: 3/7 (43%)
Deaths: 0/7

Serious adverse events (5 terms)

ReactionSystemGilteritinib 120mg + Erlot…Gilteritinib 80mg+ Erlotin…
Alanine aminotransferase increasedInvestigations——
Aspartate aminotransferase increasedInvestigations——
FractureInjury, poisoning and procedural complications——
Renal failure acuteRenal and urinary disorders——
Pleural effusionRespiratory, thoracic and mediastinal disorders——
Other adverse events (63 terms — click to expand)

ReactionSystemGilteritinib 120mg + Erlot…Gilteritinib 80mg+ Erlotin…
Drug eruptionSkin and subcutaneous tissue disorders——
Aspartate aminotransferase increasedInvestigations——
DiarrhoeaGastrointestinal disorders——
Alanine aminotransferase increasedInvestigations——
ConstipationGastrointestinal disorders——
Blood creatine phosphokinase increasedInvestigations——
Blood alkaline phosphatase increasedInvestigations——
HypoalbuminaemiaMetabolism and nutrition disorders——
Blood lactate dehydrogenase increasedInvestigations——
Dry skinSkin and subcutaneous tissue disorders——
PruritusSkin and subcutaneous tissue disorders——
ParonychiaInfections and infestations——
Decreased appetiteMetabolism and nutrition disorders——
DizzinessNervous system disorders——
MalaiseGeneral disorders——
InsomniaPsychiatric disorders——
ProteinuriaRenal and urinary disorders——
NauseaGastrointestinal disorders——
StomatitisGastrointestinal disorders——
Abdominal discomfortGastrointestinal disorders——
Abdominal distensionGastrointestinal disorders——
DyspepsiaGastrointestinal disorders——
EnteritisGastrointestinal disorders——
Gastric disorderGastrointestinal disorders——
HaemorrhoidsGastrointestinal disorders——
Oral dysaesthesiaGastrointestinal disorders——
ToothacheGastrointestinal disorders——
VomitingGastrointestinal disorders——
Blood creatinine increasedInvestigations——
Aldolase increasedInvestigations——
Amylase increasedInvestigations——
Electrocardiogram QT prolongedInvestigations——
Myoglobin blood increasedInvestigations——
Platelet count decreasedInvestigations——
Weight decreasedInvestigations——
RashSkin and subcutaneous tissue disorders——
Acne pustularInfections and infestations——
ConjunctivitisInfections and infestations——
CystitisInfections and infestations——
Gastroenteritis staphylococcalInfections and infestations——

Most-reported serious reactions: Alanine aminotransferase increased, Aspartate aminotransferase increased, Fracture, Renal failure acute, Pleural effusion.

Data from ClinicalTrials.gov NCT02495233 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. AXL receptor tyrosine kinase as a promising anti-cancer approach: functions, molecular mechanisms and clinical applications.
    Zhu C, Wei Y, Wei X. · · 2019 · cited 398× · PMID 31684958 · DOI 10.1186/s12943-019-1090-3
  2. Emerging therapeutic agents for lung cancer.
    Dholaria B, Hammond W, Shreders A, Lou Y. · · 2016 · cited 66× · PMID 27938382 · DOI 10.1186/s13045-016-0365-z
  3. The Development of AXL Inhibitors in Lung Cancer: Recent Progress and Challenges.
    Sang YB, Kim JH, Kim CG, Hong MH, et al · · 2022 · cited 45× · PMID 35311091 · DOI 10.3389/fonc.2022.811247
  4. AXL signaling in cancer: from molecular insights to targeted therapies.
    Yadav M, Sharma A, Patne K, Tabasum S, et al · · 2025 · cited 42× · PMID 39924521 · DOI 10.1038/s41392-024-02121-7
  5. Targeting AXL in NSCLC.
    Zaman A, Bivona TG. · · 2021 · cited 20× · PMID 34408519 · DOI 10.2147/lctt.s305484
  6. Tumor tissue and plasma levels of AXL and GAS6 before and after tyrosine kinase inhibitor treatment in EGFR-mutated non-small cell lung cancer.
    Nonagase Y, Takeda M, Azuma K, Hayashi H, et al · · 2019 · cited 12× · PMID 31419057 · DOI 10.1111/1759-7714.13166
  7. The Role of Proteomics and Phosphoproteomics in the Discovery of Therapeutic Targets and Biomarkers in Acquired EGFR-TKI-Resistant Non-Small Cell Lung Cancer.
    Moonmuang S, Tantraworasin A, Orrapin S, Udomruk S, et al · · 2023 · cited 6× · PMID 36902280 · DOI 10.3390/ijms24054827

Verify or expand the search:

Other trials of Gilteritinib

Trials testing the same drug.

Other recruiting trials for Non-Small-Cell Lung Cancer

Currently open trials in the same condition.

Other Astellas Pharma Global Development, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02495233.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing