<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/NCT03231501</url>
  </required_header>
  <id_info>
    <org_study_id>2016-813-00CH3</org_study_id>
    <nct_id>NCT03231501</nct_id>
  </id_info>
  <brief_title>HMPL-813 in Treating Patients With Glioblastoma</brief_title>
  <official_title>A Phase Ib, Multi-center, Open-label Study of Epitinib Succinate (HMPL-813) in Treating Patients With Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hutchison Medipharma Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hutchmed</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label study, to evaluated epitinib, which is a selective epidermal growth&#xD;
      factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with&#xD;
      EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of&#xD;
      EGFR may provide a novel mechanism in treating glioblastoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epitinib could cross BBB and show its efficacy in brain metastasis tumors. Patients with&#xD;
      histologically confirmed glioblastoma; standard treatment failed or no standard treatment as&#xD;
      well as EGFR gene amplication are eligible. Patients will receive epitinib 120mg or 160mg&#xD;
      epitinib daily. Epitinib is orally administered qd until patients reach intolerance or&#xD;
      progression of disease. Tumor assessment takes place every 4 weeks. Simon two stage design&#xD;
      was used, estimated making sample size of 35 cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 26, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a single arm, open label study with fixed dose.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>objective response rate (ORR)</measure>
    <time_frame>6 months</time_frame>
    <description>the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">29</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a single arm study. It is an open-label study. The intervention is eptinib succinate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>epitinib succinate</intervention_name>
    <description>This is a single-arm open label study. A subject would take 160 mg of the study medication (epitinib succinate) every day on a 28-day cycle, until he or she reaches disease progression or intolerability.</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed glioblastoma&#xD;
&#xD;
          2. Standard treatment failed or no standard treatment&#xD;
&#xD;
          3. EGFR gene amplification&#xD;
&#xD;
          4. Clearly measurable lesions (according to Response Assessment in Neuro-Oncolog (RANO))&#xD;
&#xD;
          5. Age ≥ 18&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) score ≤2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of Antiepileptic drugs were used] within 2 weeks before enrollment&#xD;
&#xD;
          2. Immunotherapy, anti-angiogenesis or EGFR TKI and its downstream pathway signaling&#xD;
             molecules and other targeted drugs within 4 weeks before enrollment; temozolomide&#xD;
             chemotherapy, cranial radiotherapy or other systemic anti-tumor therapy within 3 weeks&#xD;
             before enrollment&#xD;
&#xD;
          3. Previous toxic effects of anticancer therapy have not yet been recovered (defined as&#xD;
             not restored to 0 or 1 level, except alopecia) or have not been fully recovered from&#xD;
             previous surgery&#xD;
&#xD;
          4. Uncontrolled active infections such as acute pneumonia, Hepatitis B Virus (HBV) and so&#xD;
             on&#xD;
&#xD;
          5. Eye disease or dry eye syndrome history&#xD;
&#xD;
          6. Positive pregnancy tested result&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rongjun Liu, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Hutchison Medipharma Ltd.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rongjun Liu, M.D.</last_name>
    <phone>86-21-2067-3203</phone>
    <email>rongjunl@hmplglobal.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yan Wu, M.D.</last_name>
    <phone>86-21-2067-3000</phone>
    <phone_ext>5830</phone_ext>
    <email>yanwu@hmplglobal.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Huashan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200031</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin Zhang, M.D.</last_name>
      <phone>+86-13761626836</phone>
      <email>xinzhanghs@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Wei Hua, M.D.</last_name>
      <phone>+86-15800589540</phone>
      <email>hs_glioma@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ying MAO, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The second hospital affiliated to Zhejiang University Medical School</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinfang Xu, M.D.</last_name>
      <phone>+86-13757118726</phone>
      <email>xjfxyz@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Chongran Sun, M.D.</last_name>
      <phone>+86-15925612402</phone>
      <email>sunchongran@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jianmin Zhang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03231501
org study id: 2016-813-00CH3
nct id: NCT03231501
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an open-label study, to evaluated epitinib, which is a selective epidermal growth
      factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with
      EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of
      EGFR may provide a novel mechanism in treating glioblastoma.
Epitinib could cross BBB and show its efficacy in brain metastasis tumors. Patients with
      histologically confirmed glioblastoma; standard treatment failed or no standard treatment as
      well as EGFR gene amplication are eligible. Patients will receive epitinib 120mg or 160mg
      epitinib daily. Epitinib is orally administered qd until patients reach intolerance or
      progression of disease. Tumor assessment takes place every 4 weeks. Simon two stage design
      was used, estimated making sample size of 35 cases.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a single arm, open label study with fixed dose.
primary purpose: Treatment
masking: None (Open Label)
measure: objective response rate (ORR)
time frame: 6 months
description: the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
arm group label: single arm
arm group type: Experimental
description: This is a single arm study. It is an open-label study. The intervention is eptinib succinate.
intervention type: Drug
intervention name: epitinib succinate
description: This is a single-arm open label study. A subject would take 160 mg of the study medication (epitinib succinate) every day on a 28-day cycle, until he or she reaches disease progression or intolerability.
arm group label: single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Rongjun Liu, M.D.
role: Study Chair
affiliation: Hutchison Medipharma Ltd.
last name: Rongjun Liu, M.D.
phone: 86-21-2067-3203
email: rongjunl@hmplglobal.com
last name: Yan Wu, M.D.
phone: 86-21-2067-3000
phone ext: 5830
email: yanwu@hmplglobal.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Glioblastoma
sharing ipd: No