<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/NCT02209441</url>
  </required_header>
  <id_info>
    <org_study_id>BAY43</org_study_id>
    <nct_id>NCT02209441</nct_id>
  </id_info>
  <brief_title>Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced/Metastatic Gastric Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <brief_summary>
    <textblock>
      -  To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of&#xD;
           sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as&#xD;
           first-line treatment for advanced gastric cancer&#xD;
&#xD;
        -  The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide&#xD;
           elevation of the sorafenib dosage to the next level&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 proved effective and safe&#xD;
      for the treatment of advanced gastric cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <condition>Gastric Cancer.</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phase I Dose-finding Study of Sorafenib Study</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years.&#xD;
&#xD;
          -  documented gastric adenocarcinoma via histological or cytological examinations;&#xD;
&#xD;
          -  newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer;&#xD;
&#xD;
          -  no history of chemotherapy or radiation therapy; at least one lesion with a measurable&#xD;
             diameter; -&#xD;
&#xD;
          -  an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;&#xD;
&#xD;
          -  an expected survival time of at least 3 months;&#xD;
&#xD;
          -  and provision of informed consent by patients prior to commencement of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a present or past medical history of other tumors, except for cured skin cancer&#xD;
             (non-melanoma) or carcinoma in situ of the cervix;&#xD;
&#xD;
          -  surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal&#xD;
             seeding or intestinal obstruction;&#xD;
&#xD;
          -  severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy&#xD;
&#xD;
          -  a past medical history of serious neurological or psychiatric diseases; pregnancy or&#xD;
             lactation;&#xD;
&#xD;
          -  women of childbearing potential unwilling to use adequate contraception; a past&#xD;
             medical history of heart disease such as greater than grade 2 New York Heart&#xD;
             Association (NYHA) congestive heart failure, unstable coronary heart disease (patients&#xD;
             having episodes of myocardial infarction earlier than 12 months prior to the study&#xD;
             were allowed to enrol), arrhythmia requiring antiarrhythmic therapy (patients on&#xD;
             β-blockers or digoxin were allowed to enrol), or uncontrolled hypertension; severe&#xD;
             active infection&#xD;
&#xD;
          -  epileptic patients requiring medical treatment (such as corticosteroids or&#xD;
             antiepileptic drugs);&#xD;
&#xD;
          -  patients who had received immunotherapy within 4 weeks prior to or throughout the&#xD;
             study or had received mitomycin C or nitrourea drugs within 4 weeks previously;&#xD;
&#xD;
          -  allergies or possible allergies to the study medications or other drugs administered&#xD;
             during the study;&#xD;
&#xD;
          -  any patient safety or compliance issues that might jeopardize their participation in&#xD;
             the study;&#xD;
&#xD;
          -  an inability to swallow oral drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Yihebali Chi, Doctor</last_name>
    <phone>+86 13911075626</phone>
    <email>yihebalichi@hotmail.com</email>
  </overall_contact>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Shi Yuankai</investigator_full_name>
    <investigator_title>vice president</investigator_title>
  </responsible_party>
  <keyword>sorafenib, gastric cancer, FOLFOX4</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sorafenib</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/NCT02209441
org study id: BAY43
nct id: NCT02209441
lead sponsor: 
-  To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of
           sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as
           first-line treatment for advanced gastric cancer

        -  The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide
           elevation of the sorafenib dosage to the next level
-Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 proved effective and safe
      for the treatment of advanced gastric cancer.
intervention type: Drug
intervention name: Phase I Dose-finding Study of Sorafenib Study
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Yihebali Chi, Doctor
phone: +86 13911075626
email: yihebalichi@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Shi Yuankai
investigator title: vice president
mesh term: Stomach Neoplasms
mesh term: Sorafenib