<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02192697</url>
  </required_header>
  <id_info>
    <org_study_id>8273-CL-0101</org_study_id>
    <nct_id>NCT02192697</nct_id>
  </id_info>
  <brief_title>An Open Study of ASP8273 in Patients With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations</brief_title>
  <official_title>An Open-label Study of the Oral Administration of ASP8273 in Patients With Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Mutations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the study is to determine the following in patients with non-small cell lung&#xD;
      cancer (NSCLC) harboring EGFR activating mutations.&#xD;
&#xD;
        -  the safety and tolerability of ASP8273.&#xD;
&#xD;
        -  the pharmacokinetics (PK) of ASP8273.&#xD;
&#xD;
        -  the antitumor activity of ASP8273.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of Phase I and Phase II.&#xD;
&#xD;
      The objectives of Phase I are to determine the following in patients with non-small cell lung&#xD;
      cancer (NSCLC) harboring EGFR activating mutations.&#xD;
&#xD;
        -  safety and tolerability of ASP8273.&#xD;
&#xD;
        -  the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of ASP8273&#xD;
           based on the dose limiting toxicity (DLT) profile.&#xD;
&#xD;
        -  pharmacokinetics (PK) of ASP8273.&#xD;
&#xD;
        -  antitumor activity of ASP8273.&#xD;
&#xD;
      The objectives of Phase II are to determine the following at the RP2D of ASP8273 in patients&#xD;
      with NSCLC harboring EGFR mutation.&#xD;
&#xD;
        -  efficacy of ASP8273&#xD;
&#xD;
        -  safety of ASP8273&#xD;
&#xD;
        -  PK of ASP8273&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.&#xD;
  </why_stopped>
  <start_date type="Actual">January 23, 2014</start_date>
  <completion_date type="Actual">June 14, 2017</completion_date>
  <primary_completion_date type="Actual">January 15, 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase I: Safety and tolerability of ASP8273 as assessed by Dose Limiting Toxicities (DLTs)</measure>
    <time_frame>Up to Day 23</time_frame>
    <description>A DLT is defined as any pre-determined toxicity that is related to study drug per the investigator and which occurs during Cycle 0 and Cycle 1 using the Japan Clinical Oncology Group (JCOG) Japanese translation of the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver 4.0 - JCOG)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase II: Overall response rate (CR+PR) at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The overall response rate, which is defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) according to RECIST Version 1.1, will be calculated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase I: Safety and tolerability of ASP8273 as assessed by adverse events (AEs)</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a subject administered a study drug or has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase I: Safety and tolerability of ASP8273 as assessed by laboratory tests</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Laboratory tests to be conducted are hematology, biochemistry, urinalysis, coagulation profile, lipid panel and lymphocyte subpopulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase I: Safety and tolerability of ASP8273 as assessed by vital signs</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Vital signs to be measured includes blood pressure, pulse rate and temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase I: Safety and tolerability of ASP8273 as assessed by 12-lead ECG</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>including the assessment of QT intervals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase I: Plasma concentrations of unchanged ASP8273</measure>
    <time_frame>Up to Day 1 of Cycle 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase I: Urine concentrations of unchanged ASP8273</measure>
    <time_frame>Up to Day 1 of Cycle 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase I: Overall response rate (CR+PR)</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>The overall response rate is defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) according to RECIST Version 1.1, will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase I: Disease control rate (CR+PR+SD)</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>The disease control rate is defined as the proportion of subjects whose best overall response is rated as CR, PR, or stable disease (SD) according to RECIST Version 1.1, will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Plasma concentrations of unchanged ASP8273</measure>
    <time_frame>Up to Day 1 of Cycle 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Urine concentrations of unchanged ASP8273</measure>
    <time_frame>Up to Day 1 of Cycle 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Safety and tolerability of ASP8273 as assessed by adverse events (AEs)</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a subject administered a study drug or has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Safety and tolerability of ASP8273 as assessed by laboratory tests</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Laboratory tests to be conducted are hematology, biochemistry, urinalysis, coagulation profile, lipid panel and lymphocyte subpopulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Safety and tolerability of ASP8273 as assessed by vital signs</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Vital signs to be measured includes blood pressure, pulse rate and temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Safety and tolerability of ASP8273 as assessed by 12-lead ECG</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>including the assessment of QT intervals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Disease control rate</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>The disease control rate is defined as the proportion of subjects whose best overall response is rated as CR, PR, or stable disease (SD) according to RECIST Version 1.1, will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Progression-free survival (PFS)</measure>
    <time_frame>Up to 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Overall survival (OS)</measure>
    <time_frame>Up to 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Overall response rate (CR+PR)</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>The overall response rate, which is defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) according to RECIST Version 1.1, will be calculated</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Phase I dose-escalation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I EGFR-T790M mutation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase II group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP8273</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>Phase I EGFR-T790M mutation group</arm_group_label>
    <arm_group_label>Phase I dose-escalation group</arm_group_label>
    <arm_group_label>Phase II group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed diagnosis of NSCLC.&#xD;
&#xD;
          -  Patients confirmed to have the del ex19, L858R, G719X, or L861Q mutation among the&#xD;
             EGFR activating mutations (patients at the study site who are documented to have any&#xD;
             of the above-stated EGFR activating mutations can be enrolled in the study).&#xD;
&#xD;
          -  Life expectancy ≥ 12 weeks based on the investigator's/subinvestigator's judgment.&#xD;
&#xD;
          -  [Phase I]&#xD;
&#xD;
               -  Patients who have previously been treated with EGFR tyrosine-kinase inhibitors&#xD;
                  (EGFR-TKIs)*&#xD;
&#xD;
               -  Those who are not expected to show a therapeutic response to existing treatments&#xD;
                  in the investigator's/subinvestigator's opinion.&#xD;
&#xD;
          -  [Phase II]&#xD;
&#xD;
               -  Patients who have been confirmed to have progressive disease (PD) after previous&#xD;
                  treatment with EGFR-TKIs*; for those who have received 2 or more regimens of&#xD;
                  previous treatment, the last regimen before enrollment should have included&#xD;
                  EGFR-TKIs.&#xD;
&#xD;
               -  *Erlotinib, gefitinib, and EGFR-TKIs under clinical investigation (e.g.,&#xD;
                  neratinib, afatinib, dacomitinib)&#xD;
&#xD;
               -  Expression of the EGFR-T790M mutation as confirmed by a tumor biopsy of the&#xD;
                  primary or metastatic lesions after confirmation of PD following previous&#xD;
                  treatment with EGFR-TKIs and before enrollment, or by a tumor tissue sample that&#xD;
                  had been collected and archived after confirmation of PD following previous&#xD;
                  treatment with EGFR-TKIs.&#xD;
&#xD;
               -  At least 1 measurable lesion based on Response Evaluation Criteria in Solid&#xD;
                  Tumors (RECIST) Version 1.1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persistent clinical evidence of previous antitumor treatment related toxicity ≥ Grade&#xD;
             2 using the Japan Clinical Oncology Group (JCOG) Japanese translation of the National&#xD;
             Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version&#xD;
             4.0 (NCI CTCAE v4.0 - JCOG) (except alopecia and skin toxicities considered irrelevant&#xD;
             in study enrollment by the investigator/sub-investigator).&#xD;
&#xD;
          -  History of or concurrent interstitial lung disease&#xD;
&#xD;
          -  Received treatment with a reversible EGFR-TKI (erlotinib or gefitinib) within 8 days&#xD;
             before the start of the study treatment.&#xD;
&#xD;
          -  Received previous treatment (except reversible EGFR-TKIs) intended to have antitumor&#xD;
             effects or treatment with another investigational drug or an investigational device&#xD;
             within 14 days before the start of the study treatment.&#xD;
&#xD;
          -  Previously received treatment with EGFR-TKIs (e.g., CO-1686, AZD9291) that can inhibit&#xD;
             EGFR with the T790M mutation.&#xD;
&#xD;
          -  It is planned that the subject will undergo a surgical procedure during the course of&#xD;
             the study or the subject still has an unhealed wound after previous surgery&#xD;
&#xD;
          -  Symptomatic central nervous system (CNS) lesions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site: 4</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 9</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 8</name>
      <address>
        <city>Miyagi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 7</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 3</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 6</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 2</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 1</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 5</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 10</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 11</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 12</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 13</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site: 14</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>https://astellasclinicalstudyresults.com/study.aspx?ID=259</url>
    <description>Link to results on the Astellas Clinical Study Results website</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>May 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>safety</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>tolerability</keyword>
  <keyword>ASP8273</keyword>
  <keyword>Non-small Cell Lung Cancer</keyword>
  <keyword>T790M resistance mutation</keyword>
  <keyword>NSCLC</keyword>
  <keyword>Epidermal Growth Factor Receptor mutations</keyword>
  <keyword>irreversible EGFR inhibitor</keyword>
  <keyword>antitumor activity</keyword>
  <keyword>EGFR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naquotinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.</ipd_time_frame>
    <ipd_access_criteria>Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.</ipd_access_criteria>
    <ipd_url>https://www.clinicalstudydatarequest.com/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02192697
org study id: 8273-CL-0101
nct id: NCT02192697
lead sponsor: 
has dmc: No
Purpose of the study is to determine the following in patients with non-small cell lung
      cancer (NSCLC) harboring EGFR activating mutations.

        -  the safety and tolerability of ASP8273.

        -  the pharmacokinetics (PK) of ASP8273.

        -  the antitumor activity of ASP8273.
This study consists of Phase I and Phase II.

      The objectives of Phase I are to determine the following in patients with non-small cell lung
      cancer (NSCLC) harboring EGFR activating mutations.

        -  safety and tolerability of ASP8273.

        -  the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of ASP8273
           based on the dose limiting toxicity (DLT) profile.

        -  pharmacokinetics (PK) of ASP8273.

        -  antitumor activity of ASP8273.

      The objectives of Phase II are to determine the following at the RP2D of ASP8273 in patients
      with NSCLC harboring EGFR mutation.

        -  efficacy of ASP8273

        -  safety of ASP8273

        -  PK of ASP8273
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase I: Safety and tolerability of ASP8273 as assessed by Dose Limiting Toxicities (DLTs)
time frame: Up to Day 23
description: A DLT is defined as any pre-determined toxicity that is related to study drug per the investigator and which occurs during Cycle 0 and Cycle 1 using the Japan Clinical Oncology Group (JCOG) Japanese translation of the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver 4.0 - JCOG)
measure: Phase II: Overall response rate (CR+PR) at Week 24
time frame: Week 24
description: The overall response rate, which is defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) according to RECIST Version 1.1, will be calculated
measure: Phase I: Safety and tolerability of ASP8273 as assessed by adverse events (AEs)
time frame: Up to 18 months
description: An AE is defined as any untoward medical occurrence in a subject administered a study drug or has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product
measure: Phase I: Safety and tolerability of ASP8273 as assessed by laboratory tests
time frame: Up to 18 months
description: Laboratory tests to be conducted are hematology, biochemistry, urinalysis, coagulation profile, lipid panel and lymphocyte subpopulation
measure: Phase I: Safety and tolerability of ASP8273 as assessed by vital signs
time frame: Up to 18 months
description: Vital signs to be measured includes blood pressure, pulse rate and temperature
measure: Phase I: Safety and tolerability of ASP8273 as assessed by 12-lead ECG
time frame: Up to 18 months
description: including the assessment of QT intervals
measure: Phase I: Plasma concentrations of unchanged ASP8273
time frame: Up to Day 1 of Cycle 3
measure: Phase I: Urine concentrations of unchanged ASP8273
time frame: Up to Day 1 of Cycle 3
measure: Phase I: Overall response rate (CR+PR)
time frame: Up to 18 months
description: The overall response rate is defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) according to RECIST Version 1.1, will be calculated
measure: Phase I: Disease control rate (CR+PR+SD)
time frame: Up to 18 months
description: The disease control rate is defined as the proportion of subjects whose best overall response is rated as CR, PR, or stable disease (SD) according to RECIST Version 1.1, will be calculated.
measure: Phase II: Plasma concentrations of unchanged ASP8273
time frame: Up to Day 1 of Cycle 3
measure: Phase II: Urine concentrations of unchanged ASP8273
time frame: Up to Day 1 of Cycle 3
measure: Phase II: Safety and tolerability of ASP8273 as assessed by adverse events (AEs)
time frame: Up to 18 months
description: An AE is defined as any untoward medical occurrence in a subject administered a study drug or has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product
measure: Phase II: Safety and tolerability of ASP8273 as assessed by laboratory tests
time frame: Up to 18 months
description: Laboratory tests to be conducted are hematology, biochemistry, urinalysis, coagulation profile, lipid panel and lymphocyte subpopulation
measure: Phase II: Safety and tolerability of ASP8273 as assessed by vital signs
time frame: Up to 18 months
description: Vital signs to be measured includes blood pressure, pulse rate and temperature
measure: Phase II: Safety and tolerability of ASP8273 as assessed by 12-lead ECG
time frame: Up to 18 months
description: including the assessment of QT intervals
measure: Phase II: Disease control rate
time frame: Up to 18 months
description: The disease control rate is defined as the proportion of subjects whose best overall response is rated as CR, PR, or stable disease (SD) according to RECIST Version 1.1, will be calculated.
measure: Phase II: Progression-free survival (PFS)
time frame: Up to 18 months
measure: Phase II: Overall survival (OS)
time frame: Up to 18 months
measure: Phase II: Overall response rate (CR+PR)
time frame: Up to 18 months
description: The overall response rate, which is defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) according to RECIST Version 1.1, will be calculated
arm group label: Phase I dose-escalation group
arm group type: Experimental
description: Oral administration
arm group label: Phase I EGFR-T790M mutation group
arm group type: Experimental
description: Oral administration
arm group label: Phase II group
arm group type: Experimental
description: Oral administration
intervention type: Drug
intervention name: ASP8273
description: Oral administration
arm group label: Phase I EGFR-T790M mutation group
arm group label: Phase I dose-escalation group
arm group label: Phase II group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Inc
facility: 
facility: 
facility: 
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country: Japan
country: Korea, Republic of
country: Taiwan
url: https://astellasclinicalstudyresults.com/study.aspx?ID=259
description: Link to results on the Astellas Clinical Study Results website
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Naquotinib
sharing ipd: Yes
ipd description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
ipd access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
ipd url: https://www.clinicalstudydatarequest.com/