<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/NCT03282825</url>
  </required_header>
  <id_info>
    <org_study_id>DW1018-I-1</org_study_id>
    <nct_id>NCT03282825</nct_id>
  </id_info>
  <brief_title>Clinical Study of Decitabine and Paclitaxel Combination Therapy</brief_title>
  <official_title>An Open-labelled, Parallel, Multiple Ascending Dose, Phase Ib Clinical Study of Decitabine and Paclitaxel Combination Therapy in Treating Patients With Metastatic and Locally Advanced Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong Wha Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong Wha Pharmaceutical Co. Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase Ib clinical study of Decitabine and Paclitaxel combination therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-labelled, parallel, multiple ascending dose, phase Ib clinical study of Decitabine&#xD;
      and Paclitaxel combination therapy in treating patients with metastatic and locally advanced&#xD;
      breast cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 28, 2017</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</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>Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)</measure>
    <time_frame>for about 4 weeks</time_frame>
    <description>According to principle of Dose Limited Toxicity (DLT) assessment by National Cancer Institute Common Terminonlgy Criteria for Adverse Events (NCI-CTCAE, V4.0), DLT is evaluated above grade 3 as adverse event.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Advanced Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Decitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A standard 3+3 trial design will be used for Decitabine dose escalation cohorts.&#xD;
The number of cohorts is three. The subjects will be administered Decitabine on every seven days in a 28day cycle and Decitabine is sequential administered with Paclitaxel.&#xD;
Cohort 1: Decitabine 15mg/m2, Cohort 2: Decitabine 20mg/m2, Cohort 3: Decitabine 25mg/m2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion.&#xD;
Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.</description>
    <arm_group_label>Decitabine</arm_group_label>
    <other_name>DW1018</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion.&#xD;
Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.</description>
    <arm_group_label>Decitabine</arm_group_label>
    <other_name>combination therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥ 19 years as female&#xD;
&#xD;
          2. be unable to operate for therapy with HER2 negative breast adenocarcinoma and&#xD;
             metastatic breast cancer, one or more chemotherapy&#xD;
&#xD;
          3. according to RECIST ver.1.1, one or more evaluable lesion&#xD;
&#xD;
          4. Eastern cooperative oncology group(ECOG) performance score is o or 1&#xD;
&#xD;
          5. lesion for core biopsy&#xD;
&#xD;
          6. Within 28days of planned first study treatment day, laboratory safety test is&#xD;
             satisfied. ANC ≥1500cells/microliter, Platelet count ≥ 100,000 cells/microliter,&#xD;
             Hemoglobin≥8.5g/dl, ALT and AST ≤ 2ULN, ALP≤2.5ULN, Serum total bilirubin≤1.25 ULN,&#xD;
             PT-INR and aPTT≤1.5ULN, Creatinine≥50ml/min&#xD;
&#xD;
          7. menopause or informed that effective contraception must be used during the entire&#xD;
             treatment period of this study and for 6 months after exiting from the study&#xD;
&#xD;
          8. Given signed and dated written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Symptomatic metastasis and Leptomeningeal metastasis&#xD;
&#xD;
          2. Injection of paclitaxel for metastatic breast cancer within 6 months&#xD;
&#xD;
          3. HER2, Positive Breast adenocarcinoma&#xD;
&#xD;
          4. cancertherapy for whole body within 3 weeks&#xD;
&#xD;
          5. radiotherapy for metastatic region within 4 weeks&#xD;
&#xD;
          6. major surgery, open biopsy and trauma within 4 weeks&#xD;
&#xD;
          7. less than 4 weeks post major surgery&#xD;
&#xD;
          8. treatment with consistently systemic corticosteroid or immunosuppressive drug&#xD;
&#xD;
          9. more than 2 grade for peripheral neuropathy&#xD;
&#xD;
         10. Congenital ling QT syndrome or QTc interval &gt; 480 milisecond&#xD;
&#xD;
         11. occur myocardial infartion within 6 months&#xD;
&#xD;
         12. unstable angina pectoris&#xD;
&#xD;
         13. HIV(+) or AIDS&#xD;
&#xD;
         14. HBsAg(+) or HCV(+)&#xD;
&#xD;
         15. treatment bisphosphonate for hypercalcemia&#xD;
&#xD;
         16. except metastatic and locally advanced breast cancer, personal history with malignancy&#xD;
             within 5 years&#xD;
&#xD;
         17. hypersensitivity reaction with paclitaxel or Cremophor EL formulation&#xD;
&#xD;
         18. Pregnant or breast feeding&#xD;
&#xD;
         19. be unable or unwilling to abide by the study protocol or to cooperate fully with the&#xD;
             investigator or designee&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joo Hyuk Sohn, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yonsei University Health System, Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yonsei University Health System, Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>January 21, 2018</last_update_submitted>
  <last_update_submitted_qc>January 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</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>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Decitabine</mesh_term>
  </intervention_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/NCT03282825
org study id: DW1018-I-1
nct id: NCT03282825
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Phase Ib clinical study of Decitabine and Paclitaxel combination therapy
An open-labelled, parallel, multiple ascending dose, phase Ib clinical study of Decitabine
      and Paclitaxel combination therapy in treating patients with metastatic and locally advanced
      breast cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)
time frame: for about 4 weeks
description: According to principle of Dose Limited Toxicity (DLT) assessment by National Cancer Institute Common Terminonlgy Criteria for Adverse Events (NCI-CTCAE, V4.0), DLT is evaluated above grade 3 as adverse event.
arm group label: Decitabine
arm group type: Experimental
description: A standard 3+3 trial design will be used for Decitabine dose escalation cohorts.
The number of cohorts is three. The subjects will be administered Decitabine on every seven days in a 28day cycle and Decitabine is sequential administered with Paclitaxel.
Cohort 1: Decitabine 15mg/m2, Cohort 2: Decitabine 20mg/m2, Cohort 3: Decitabine 25mg/m2
intervention type: Drug
intervention name: Decitabine
description: The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion.
Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.
arm group label: Decitabine
other name: DW1018
intervention type: Drug
intervention name: Paclitaxel
description: The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion.
Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.
arm group label: Decitabine
other name: combination therapy
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Joo Hyuk Sohn, MD, PhD
role: Principal Investigator
affiliation: Yonsei University Health System, Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Paclitaxel
mesh term: Decitabine
sharing ipd: No