Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Tyrosine Kinase Inhibitors

Gilteritinib

Erlotinib Hydrochloride

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Gilteritinib was administered in combination with erlotinib orally once daily.

Erlotinib

Senior Medical Director

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.

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)

A Phase 1b/2 Study of ASP2215 in Combination With Erlotinib in Subjects With EGFR Activating Mutation-Positive (EGFRm+) Advanced NSCLC Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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.

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

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.

Astellas Pharma Global Development, Inc.

Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.

Gilteritinib 120mg + Erlotinib 150mg

Gilteritinib 80mg+ Erlotinib 150mg

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Clinical Trial Disclosure

Cycle 1

Cycle ≥2

Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs. DLT evaluable set (DES), was a subset of SAF and included participants who were either administered with at least 75% of planned dose during cycle 1 or experienced DLT during cycle 1.

Number of Participants With Dose Limiting Toxicities (DLTs)

Any TEAEs

Drug-related TEAEs

TEAEs leading to death

Serious TEAEs

Drug-related serious TEAEs

TEAEs leading to withdrawal of treatment

Drug-related TEAEs leading to withdrawal of treat.

Number of Participants With Adverse Events

Cycle 1 Day 1

Cycle 1 Day 28

Pharmacokinetic Analysis Set (PKAS) consisted of all participants who received at least 1 dose of study drugs for whom sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of dosing on the day of sampling was known.

Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib

Maximum Concentration (Cmax) for Gilteritinib

Cycle 1 Day 1,

Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib

Predose on Day 1 of cycle 1

Predose on Day 3 of cycle 1

Predose on Day 8 of cycle 1

Predose on Day 15 of cycle 1

Predose on Day 22 of cycle 1

Predose on Day 28 of cycle 1

Predose on Day 1 of cycle 3

Predose on Day 1 of cycle 4

Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib

Spots Global Cancer Trial Database for 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)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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