<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/NCT01678690</url>
  </required_header>
  <id_info>
    <org_study_id>HR-11-001</org_study_id>
    <nct_id>NCT01678690</nct_id>
  </id_info>
  <brief_title>An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors</brief_title>
  <official_title>An Open-Label, Exploratory, Limited Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InnoPharmax Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InnoPharmax Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort),&#xD;
      to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4)&#xD;
      administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and&#xD;
      safety will also be assessed during this 1-week period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Early 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC</measure>
    <time_frame>Day 1-5</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the proportion of subjects experiencing adverse events all grades, change from baseline in clinical laboratory test results, vital sign measurements, and physical examination findings</measure>
    <time_frame>Day 1-8 (+/- 1) days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Malignant Tumors</condition>
  <arm_group>
    <arm_group_label>Gemcitabine HCl Oral Formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be treated with Gemcitabine HCl Oral Formulation according to assigned cohort (2 mg or 5 mg or 10 mg) on Day 1 of the 7-day study treatment period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine HCl Oral Formulation</intervention_name>
    <description>Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period</description>
    <arm_group_label>Gemcitabine HCl Oral Formulation</arm_group_label>
    <other_name>D07001-F4</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects aged 18 years and older.&#xD;
&#xD;
          2. Signed and dated informed consent form.&#xD;
&#xD;
          3. Subjects with malignancies with histological or pathologic confirmation and who are&#xD;
             clinically stable.&#xD;
&#xD;
          4. History of treatment with at least 1 cytotoxic chemotherapy regimen for the current&#xD;
             malignancy.&#xD;
&#xD;
          5. If the subject has received cytotoxic chemotherapy within the past 14 days, the&#xD;
             subject is beyond the nadir of white blood cell and platelet counts.&#xD;
&#xD;
          6. At least 28 days have elapsed since the subject's prior radiotherapy or any major&#xD;
             surgery (excluding diagnostic biopsy or venous access device placement).&#xD;
&#xD;
          7. World Health Organization (WHO) performance status 0 to 2&#xD;
&#xD;
          8. Subject has an ANC ≥1500 cells/mm³, platelet count ≥ 100,000 cells/mm³, and hemoglobin&#xD;
             ≥ 9 g/dL.&#xD;
&#xD;
          9. Subject has adequate liver function demonstrated by transaminases within normal limits&#xD;
             (aspartate transaminase and alanine transaminase), total bilirubin ≤ 1.5 mg/dL (unless&#xD;
             due to Gilbert's syndrome), albumin ≥ 2.5 g/dL, international normalized ratio [INR] &lt;&#xD;
             1.5).&#xD;
&#xD;
         10. Subject has adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal.&#xD;
&#xD;
         11. Subject has a life expectancy &gt;24 weeks.&#xD;
&#xD;
         12. If a women of child-bearing potential, subject has a negative pregnancy test and is&#xD;
             not breast-feeding.&#xD;
&#xD;
         13. If a women of child-bearing potential, subject is using a medically acceptable form of&#xD;
             birth control prior to screening and for the duration of their study participation and&#xD;
             for 1 month after the end of the study.&#xD;
&#xD;
         14. Subject is willing to comply with protocol-required visit schedule and visit&#xD;
             requirements and provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has rapidly progressive disease or rapid clinical deterioration as assessed by&#xD;
             the Investigator.&#xD;
&#xD;
          2. Subject is receiving full-dose (therapeutic) anticoagulation therapy.&#xD;
&#xD;
          3. Subject is receiving concomitant radiotherapy.&#xD;
&#xD;
          4. Subject is intolerant or allergic or has a known hypersensitivity to gemcitabine.&#xD;
&#xD;
          5. Subject has clinically significant cardiovascular disease (for example: uncontrolled&#xD;
             hypertension, unstable angina, congestive heart failure, or New York Heart Association&#xD;
             Grade 2 or greater).&#xD;
&#xD;
          6. Subject has uncontrolled serious cardiac arrhythmia.&#xD;
&#xD;
          7. Subject has known active brain metastases, or any leptomeningeal metastases.&#xD;
&#xD;
          8. Subject has a history of drug or alcohol abuse within last year.&#xD;
&#xD;
          9. Subject has documented cerebrovascular disease.&#xD;
&#xD;
         10. Subject has a seizure disorder not controlled on medication.&#xD;
&#xD;
         11. Subject received an investigational agent within 30 days of screening.&#xD;
&#xD;
         12. Subject received systemic treatment for infection within 14 days of screening.&#xD;
&#xD;
         13. Subject has known human immunodeficiency virus infection or viral hepatitis.&#xD;
&#xD;
         14. Subject has any other serious medical condition that, in the investigator's medical&#xD;
             opinion, would preclude safe participation in a clinical trial.&#xD;
&#xD;
         15. Subject has gastrointestinal disease or prior gastrointestinal surgery that may&#xD;
             interfere with adequate oral therapy absorption.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nashat Y. Gabrail, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gabrail Cancer Center Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sharad Ghamande, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Augusta University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chia-Chi Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgia Regents University- Cancer Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center Research</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center Research</name>
      <address>
        <city>Dover</city>
        <state>Ohio</state>
        <zip>44622</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>August 31, 2016</last_update_submitted>
  <last_update_submitted_qc>August 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 2, 2016</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>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</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/NCT01678690
org study id: HR-11-001
nct id: NCT01678690
lead sponsor: 
has dmc: No
Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort),
      to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4)
      administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and
      safety will also be assessed during this 1-week period.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC
time frame: Day 1-5
measure: the proportion of subjects experiencing adverse events all grades, change from baseline in clinical laboratory test results, vital sign measurements, and physical examination findings
time frame: Day 1-8 (+/- 1) days
arm group label: Gemcitabine HCl Oral Formulation
arm group type: Experimental
description: Subjects will be treated with Gemcitabine HCl Oral Formulation according to assigned cohort (2 mg or 5 mg or 10 mg) on Day 1 of the 7-day study treatment period
intervention type: Drug
intervention name: Gemcitabine HCl Oral Formulation
description: Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period
arm group label: Gemcitabine HCl Oral Formulation
other name: D07001-F4
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nashat Y. Gabrail, MD
role: Principal Investigator
affiliation: Gabrail Cancer Center Research
last name: Sharad Ghamande, MD
role: Principal Investigator
affiliation: Augusta University
last name: Chia-Chi Lin, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
facility: 
facility: 
facility: 
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Gemcitabine