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)

NCT02495233 | Terminated Phase 1 Results

• 1 other identifier: 2215-CL-5101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Non-Small-Cell Lung Cancer

Keywords

Erlotinib; ASP2215; NSCLC; Gilteritinib; Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limiting Toxicities (DLTs)

  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.

  From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)

Secondary Outcomes (9)

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

  0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1

• Maximum Concentration (Cmax) for Gilteritinib

  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

  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

  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

  0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1

Study Arms (2)

Gilteritinib 120mg + Erlotinib 150mg

EXPERIMENTAL

Gilteritinib was administered in combination with erlotinib orally once daily.

Drug: Gilteritinib; Drug: Erlotinib

Gilteritinib 80mg+ Erlotinib 150mg

EXPERIMENTAL

Gilteritinib was administered in combination with erlotinib orally once daily.

Drug: Gilteritinib; Drug: Erlotinib

Interventions

Gilteritinib DRUG

oral

Gilteritinib 120mg + Erlotinib 150mg; Gilteritinib 80mg+ Erlotinib 150mg

Erlotinib DRUG

oral

Also known as: Tarceva

Gilteritinib 120mg + Erlotinib 150mg; Gilteritinib 80mg+ Erlotinib 150mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant had histologically or cytologically confirmed metastatic or locally advanced, unresectable non-small-cell lung cancer (NSCLC).
• Participant had a documented exon 19 deletion or exon 21 L858R EGFR activating mutation.
• Participant had received prior treatment with any EGFR tyrosine kinase inhibitor
• Participant had Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 at screening.
• Participant had adequate organ function.
• Female participant must either:
• Be of nonchildbearing potential:
• Or, if of childbearing potential,
• Agree not to try to become pregnant during the study and for 45 days after the final study drug administration
• And had a negative serum pregnancy test at screening
• And, if heterosexually active, agreed to consistently use 2 forms of highly effective birth control
• Male participant and their female spouse/partners who were of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control
• Phase 1b Participants only:
• Participant was not expected to show a therapeutic response to existing available treatment.
• Intervening anticancer treatment subsequent to the EGFR TKI was allowed (but not required).

You may not qualify if:

• Participant had an ongoing toxicity greater than or equal to grade 3 (NCI CTCAE version 4.03) attributable to prior NSCLC treatment at the time of screening.
• 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).
• Participant received ASP2215 previously.
• Participant received blood transfusions or hematopoietic growth factor therapy within 14 days prior to the first dose of study drug.
• Participant had a major surgical procedure (other than study-related biopsy) within 14 days prior to the first dose of study drug, or a major surgical procedure was planned to occur during the study.
• Participant had active hepatitis B or C or other active hepatic disorder.
• Participant t was known to have human immunodeficiency virus (HIV) infection.
• Participant had symptomatic central nervous system (CNS) metastasis. Participants with asymptomatic, untreated CNS metastases were allowed. Participants with previously treated and currently asymptomatic CNS metastases were eligible provided they met the following:
• Any whole brain radiotherapy (WBRT) was completed at least 2 weeks prior to the first dose of study drug.
• Any stereotactic radiosurgery (SRS) was completed at least 1 week prior to the first dose of study drug.
• Participant did not require steroids or did not require escalating doses of steroids for at least 2 weeks prior to the first dose of study drug.
• Participant had evidence of active infection requiring systemic therapy within 14 days prior to the first dose of study drug.
• Participant had uncontrolled hypertension.
• Participant had severe or uncontrolled systemic diseases or active bleeding diatheses.
• Participant had history of drug-induced interstitial lung disease or any evidence of active interstitial lung disease.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (4)

Site JP81004

Fukuoka Minami-ku, Fukuoka, Japan

Location

Site JP81005

Osakasayama, Osaka, Japan

Location

Site JP81003

Suntogun Nagaizumicho,Shizuoka, Japan

Location

Site JP81002

Tokyo, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

gilteritinib; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Astellas Pharma Global Development, Inc.

astellas.resultsdisclosure@astellas.com

800-888-7704

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 13, 2015
• Study Start: September 8, 2015
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: November 27, 2024
• Results First Posted: February 15, 2019

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)