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Trial record 18 of 25 for:    ASP 2215 OR Gilteritinib

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)

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ClinicalTrials.gov Identifier: NCT02495233
Recruitment Status : Terminated (Study terminated due to adverse events related to the combination therapy)
First Posted : July 13, 2015
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: Gilteritinib Drug: Erlotinib Phase 1 Phase 2

Detailed Description:
No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : September 8, 2015
Actual Primary Completion Date : September 28, 2016
Actual Study Completion Date : September 28, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gilteritinib 120mg + Erlotinib 150mg
Gilteritinib was administered in combination with erlotinib orally once daily.
Drug: Gilteritinib
oral

Drug: Erlotinib
oral
Other Name: Tarceva

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

Drug: Erlotinib
oral
Other Name: Tarceva




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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib [ 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 ]
    All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.

  5. AUC24 of Erlotinib [ Time Frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1 ]
  6. Cmax of Erlotinib [ Time Frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1 ]
  7. Tmax of Erlotinib [ Time Frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1 ]
  8. Ctrough of Erlotinib [ Time Frame: Day 8, 15, 22, 28 of cycle 1 ]
  9. Objective Response Rate (ORR) in Phase 1b [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

IInclusion Criteria:

  • 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,

      1. Agree not to try to become pregnant during the study and for 45 days after the final study drug administration
      2. And had a negative serum pregnancy test at screening
      3. 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).
  • Additional inclusion criteria for phase 2 Participants only:

    • Participant had a NSCLC tissue sample obtained after participant developed resistance to EGFR TKI therapy that was available for central testing.
    • Participant's baseline tumor specimen (obtained after participant developed resistance to EGFR TKI therapy) is T790M negative.
    • Participant received an EGFR TKI for at least 6 months and progressed on this therapy within the past 28 days.
    • Participant had not had any intervening anticancer treatment subsequent to the EGFR TKI with the exception of radiotherapy which was allowed if it occurred at least 14 days prior to the first dose of study drug.
    • Participant had at least 1 measureable lesion (not including any lesion that was irradiated) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria:

  • 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.
  • Participant had ongoing cardiac arrhythmia (including atrial fibrillation) that was grade ≥ 2.
  • Participant currently had Class 3 or 4 New York Heart Association congestive heart failure.
  • Participant had history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the first dose of study drug.
  • Participant had history of gastrointestinal ulcer within 28 days prior to the first dose of study drug.
  • Participant had a history of gastrointestinal bleeding within 90 days prior to the first dose of study drug.
  • Participant had concurrent corneal disorder or any ophthalmologic condition which makes the participant unsuitable for study participation .
  • Participant had any condition which made the participant unsuitable for study participation.
  • Participant had hypokalemia or hypomagnesemia at screening.
  • Participant had QTcF interval > 450 ms on 12-lead ECG at screening.
  • Participant was known to have long QT syndrome.
  • Participant was taking medication known to prolong the QT interval.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495233


Locations
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Japan
Site JP81004
Fukuoka Minami-ku, Fukuoka, Japan
Site JP81005
Osakasayama, Osaka, Japan
Site JP81003
Suntogun Nagaizumicho,Shizuoka, Japan
Site JP81002
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
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Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.

Additional Information:
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02495233     History of Changes
Other Study ID Numbers: 2215-CL-5101
First Posted: July 13, 2015    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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."
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Erlotinib
ASP2215
NSCLC
Gilteritinib
Non-Small-Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action