<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/NCT03001609</url>
  </required_header>
  <id_info>
    <org_study_id>AC201606AVTN06</org_study_id>
    <nct_id>NCT03001609</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Absorption, Metabolism and Excretion of [14C] AC0010 in Patients With Advanced NSCLC</brief_title>
  <official_title>An Open-Label, Non-Randomized, Single-Center Study to Determine the Absorption, Metabolism and Excretion of A Single Dose [14C] AC0010 in Patients With Advanced NSCLC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hangzhou ACEA Pharmaceutical Research Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hangzhou ACEA Pharmaceutical Research 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 purpose of this study is to investigate Pharmacokinetics parameters of a single dose&#xD;
      [14C] AC0010 in male Patients With Advanced NSCLC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the Absorption, Metabolism, Excretion and&#xD;
      Pharmacokinetics of a single dose [14C] AC0010 in male Patients With Advanced NSCLC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics, Cumalative excretion and Metabolite of 14C-labeled AC0010</measure>
    <time_frame>up to 8 Days</time_frame>
    <description>Pharmacokinetics of 14C-labeled AC0010 Radioactivity in whole blood and plasma,Cumulative excretion of 14C-labeled AC0010 radioactivity in feces and urine,Metabolite identification of 14C-labeled AC0010 in plasma, urine and feces</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative analysis of plasma concentrations of unlabeled AC0010</measure>
    <time_frame>up to 8 Days</time_frame>
    <description>Quantitative analysis of plasma concentrations of unlabeled AC0010 using a validated LC-MS/MS method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events (AE) experienced by patients</measure>
    <time_frame>up to 8 Days</time_frame>
    <description>Number of adverse events (AE) experienced by patients to assess safety and tolerability</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>AC0010</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>each participant will be given a single dose of 14C-labeled AC0010</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AC0010</intervention_name>
    <description>Oral dose of 14C-labeled AC0010 suspension including 200 mg/83μCi[14C]</description>
    <arm_group_label>AC0010</arm_group_label>
    <other_name>14C-labeled AC0010 oral</other_name>
    <other_name>AC0010MA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed and dated informed consent&#xD;
&#xD;
          -  histologically or cytologically confirmed diagnosis of local advanced or recurrent&#xD;
             NSCLC&#xD;
&#xD;
          -  failed to the treatment of EGFR-TKI and harbored T790M mutation&#xD;
&#xD;
          -  male, Age 18~ 65, have a body mass index (BMI) &gt;19 kg/m2&#xD;
&#xD;
          -  ECOG PS:0-1,Life expectancy of more than 3 months&#xD;
&#xD;
          -  main organs function is normal, laboratory values as listed below: blood test without&#xD;
             blood transfusion within 14 days&#xD;
&#xD;
               1. Haemoglobin &gt;100 g/L&#xD;
&#xD;
               2. Absolute neutrophil count ≥2.0x10^9/L or WBC ≥3.5 x10^9/L&#xD;
&#xD;
               3. Platelet count ≥ 80x10^9/L&#xD;
&#xD;
               4. Total bilirubin ≤1.5xULN&#xD;
&#xD;
               5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times&#xD;
                  upper limit of normal (ULN)&#xD;
&#xD;
               6. BUN≤1.5xULN&#xD;
&#xD;
               7. Serum creatinine ≤1.5xULN or creatinine clearance ratio ≥60 mL/min&#xD;
&#xD;
          -  Any prior treatment (chemotherapy, radiotherapy or surgery) must be completed over 4&#xD;
             weeks(target therapy over 2 weeks) from the screening; Patients must have recovered&#xD;
             from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03)&#xD;
&#xD;
          -  International normalized ratio (INR) ≤ 1.5&#xD;
&#xD;
          -  Patients and their partners should be willing to use methods of contraception or total&#xD;
             abstinence from start of dosing until 6 months after discontinuing of study treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treated with AC0010 or allergic to drug or its formulation ingredients&#xD;
&#xD;
          -  Patients receiving other anti-tumor therapy&#xD;
&#xD;
          -  Impairment of GI disease, renal disorders or liver disease that may significantly&#xD;
             alter the absorption and metabolic of AC0010 (e.g., Unable to swallow, liver, kidney&#xD;
             or gastrointestinal partial resection, chronic diarrhea and intestinal obstruction)&#xD;
&#xD;
          -  HCVAb positive, active hepatitis B (excluding HBV carriers), Hepatitis virus markers&#xD;
             positive and receiving anti-virus drugs&#xD;
&#xD;
          -  Meningeal metastasis; brain metastasis with whole brain radiotherapy; prior received&#xD;
             hormones or mannitol for the brain metastasis&#xD;
&#xD;
          -  Previous EGFR-TKI treatment related Interstitial lung disease history&#xD;
&#xD;
          -  Known human immunodeficiency virus infection (HIV), other acquired or congenital&#xD;
             immunodeficiency disease, or a history of organ transplantation&#xD;
&#xD;
          -  Any severe and / or uncontrolled active infections&#xD;
&#xD;
          -  Patients receiving concomitant immunosuppressive agents or high-dose corticosteroids&#xD;
&#xD;
          -  Any severe and / or uncontrolled medical conditions&#xD;
&#xD;
          -  Patients being treated with drugs recognized as being inhibitors or inducers of the&#xD;
             liver isoenzyme in the last 4 weeks prior to registration in the current study&#xD;
&#xD;
          -  Within 3 days prior to the treatment intaking of pitaya, pomelo, grapefruit, orange,&#xD;
             mango and other fruit may affect drug metabolizing enzymes or juice&#xD;
&#xD;
          -  Within 2 days prior to the treatment intaking of coffee, tea, cola, chocolate, or&#xD;
             other caffeine containing beverages, alcoholic beverages and / or other alcoholic&#xD;
             products&#xD;
&#xD;
          -  Major surgery, incisional biopsy or traumatic injuries;&#xD;
&#xD;
          -  Within 4 weeks prior to the screening patients with bleeding ≥ grade 3, non-healing&#xD;
             wound, sever ulcer or bone fracture&#xD;
&#xD;
          -  Patients received high dose irradiation treatment or other 14C-labeled drug within 1&#xD;
             year&#xD;
&#xD;
          -  Known a history of alcoholism or drug abuse&#xD;
&#xD;
          -  Nicotine or urine drug testing was positive&#xD;
&#xD;
          -  Participate in any clinical trial within 4 weeks prior to the screening&#xD;
&#xD;
          -  Investigator judgment that patient is unsuitable to participate in study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Feng Shao, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yongqian Shu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lihua Bao, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</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>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abivertinib</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03001609
org study id: AC201606AVTN06
nct id: NCT03001609
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate Pharmacokinetics parameters of a single dose
      [14C] AC0010 in male Patients With Advanced NSCLC.
The purpose of this study is to investigate the Absorption, Metabolism, Excretion and
      Pharmacokinetics of a single dose [14C] AC0010 in male Patients With Advanced NSCLC.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetics, Cumalative excretion and Metabolite of 14C-labeled AC0010
time frame: up to 8 Days
description: Pharmacokinetics of 14C-labeled AC0010 Radioactivity in whole blood and plasma,Cumulative excretion of 14C-labeled AC0010 radioactivity in feces and urine,Metabolite identification of 14C-labeled AC0010 in plasma, urine and feces
measure: Quantitative analysis of plasma concentrations of unlabeled AC0010
time frame: up to 8 Days
description: Quantitative analysis of plasma concentrations of unlabeled AC0010 using a validated LC-MS/MS method
measure: Number of adverse events (AE) experienced by patients
time frame: up to 8 Days
description: Number of adverse events (AE) experienced by patients to assess safety and tolerability
arm group label: AC0010
arm group type: Experimental
description: each participant will be given a single dose of 14C-labeled AC0010
intervention type: Drug
intervention name: AC0010
description: Oral dose of 14C-labeled AC0010 suspension including 200 mg/83μCi[14C]
arm group label: AC0010
other name: 14C-labeled AC0010 oral
other name: AC0010MA
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Feng Shao, Doctor
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Yongqian Shu, Doctor
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Lihua Bao, Doctor
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Abivertinib