<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/NCT04438044</url>
  </required_header>
  <id_info>
    <org_study_id>ICP-CL-00106</org_study_id>
    <nct_id>NCT04438044</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL</brief_title>
  <official_title>A Phase II, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Recurrent/Refractory Central Nervous System Lymphoma and Recurrent/Refractory Secondary Central Nervous System Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing InnoCare Pharma Tech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing InnoCare Pharma Tech Co., Ltd.</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>
      The phase II clinical study is to investigate the safety, tolerability, efficacy and&#xD;
      pharmacokinetics of ICP-022.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with&#xD;
      Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory&#xD;
      Secondary Central Nervous System Lymphoma (SCNSL) will be evaluated in approximately 82&#xD;
      subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 18, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The efficacy measured by overall response rate (ORR)</measure>
    <time_frame>Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The occurrence of adverse events and serious adverse events</measure>
    <time_frame>every cycle, first cycle every week. Each cycle is 28 days</time_frame>
    <description>The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The efficacy measured by progression free survival (PFS)</measure>
    <time_frame>cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The efficacy measured by duration of response (DOR)</measure>
    <time_frame>cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>PCNSL</condition>
  <condition>Secondary Central Nervous System Lymphoma</condition>
  <arm_group>
    <arm_group_label>ICP-022</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150mg,QD</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ICP-022</intervention_name>
    <description>ICP-022 The drug product is a white, round, uncoated tablet</description>
    <arm_group_label>ICP-022</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Men and women ≥ 18, and ≤75 years of age&#xD;
&#xD;
          2. Histologically documented PCNSL, or histologically documented systemic diffuse large&#xD;
             B-cell lymphoma (DLBCL) for SCNSL.&#xD;
&#xD;
          3. Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4&#xD;
             systemic treatments.&#xD;
&#xD;
          4. ECOG performance status of 0-2&#xD;
&#xD;
          5. Able to provide signed written informed consent&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded&#xD;
&#xD;
          2. T-cell lymphoma.&#xD;
&#xD;
          3. Patient requires more than 8 mg of dexamethasone daily or the equivalent.&#xD;
&#xD;
          4. Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy&#xD;
             (except for alopecia)&#xD;
&#xD;
          5. Known active infection with HBV, HCV or HIV.&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital affiliated to Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Medical University Xuanwu Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital affiliated to Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Recurrent or refractory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Neoplasm Metastasis</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/NCT04438044
org study id: ICP-CL-00106
nct id: NCT04438044
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The phase II clinical study is to investigate the safety, tolerability, efficacy and
      pharmacokinetics of ICP-022.
Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with
      Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory
      Secondary Central Nervous System Lymphoma (SCNSL) will be evaluated in approximately 82
      subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The efficacy measured by overall response rate (ORR)
time frame: Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
measure: The occurrence of adverse events and serious adverse events
time frame: every cycle, first cycle every week. Each cycle is 28 days
description: The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria
measure: The efficacy measured by progression free survival (PFS)
time frame: cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
measure: The efficacy measured by duration of response (DOR)
time frame: cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days
arm group label: ICP-022
arm group type: Experimental
description: 150mg,QD
intervention type: Drug
intervention name: ICP-022
description: ICP-022 The drug product is a white, round, uncoated tablet
arm group label: ICP-022
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Neoplasm Metastasis
sharing ipd: No