<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/NCT02251951</url>
  </required_header>
  <id_info>
    <org_study_id>CT/12.05</org_study_id>
    <nct_id>NCT02251951</nct_id>
  </id_info>
  <brief_title>Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer</brief_title>
  <official_title>A Multicenter, Phase II, Single-Arm Clinical Trial of Nab-Paclitaxel as Salvage Treatment for Patients With Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal Junction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hellenic Oncology Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hellenic Oncology Research Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II&#xD;
      trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and&#xD;
      gastro-esophageal junction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line&#xD;
      chemotherapy are considered as an orphan disease with limited (if any) treatment options. The&#xD;
      promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials&#xD;
      conducted in breast cancer patients open the field to develop such therapeutic approaches in&#xD;
      other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We&#xD;
      design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage&#xD;
      treatment for patients with advanced cancer of the stomach and GEJ previously treated with&#xD;
      the DCF regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Overall Response Rate</measure>
    <time_frame>Disease evaluation every 8 weeks up to 108 weeks</time_frame>
    <description>Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>Disease evaluation every 8 weeks up to 108 weeks</time_frame>
    <description>Documented disease control rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Up to 108 weeks</time_frame>
    <description>From date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 108 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to 108 weeks</time_frame>
    <description>From date of randomization until the date of last follow up or death from any cause, assessed up to 108 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Every two weeks up to 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Stomach and Gastro-Esophageal Junction (GEJ) Cancer</condition>
  <arm_group>
    <arm_group_label>nab-Paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abraxane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nab-Paclitaxel</intervention_name>
    <description>Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d)</description>
    <arm_group_label>nab-Paclitaxel</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years old&#xD;
&#xD;
          -  Disease progression after treatment with the DCF regimen&#xD;
&#xD;
          -  Assessable target lesion(s) as defined by RECIST criteria&#xD;
&#xD;
          -  ECOG performance status ≤ 1&#xD;
&#xD;
          -  Estimated life expectancy more than 3 months&#xD;
&#xD;
          -  Serum bilirubin less than 1.5 times the upper normal limit&#xD;
&#xD;
          -  Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper&#xD;
             normal limit&#xD;
&#xD;
          -  Creatinine Clearance ≥50 ml/min&#xD;
&#xD;
          -  Neutrophil count more than 1.5x 109 /L&#xD;
&#xD;
          -  Platelet count more than 100x 109 /L&#xD;
&#xD;
          -  Hemoglobin more than 8g/dL&#xD;
&#xD;
          -  Before patient enrollment, written informed consent must be given according to Good&#xD;
             Clinical Practice guidelines and national/local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastrointestinal bleeding&#xD;
&#xD;
          -  Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's&#xD;
             discomfort&#xD;
&#xD;
          -  CNS metastases&#xD;
&#xD;
          -  Subject pregnant or breast feeding, or planning to become pregnant within 6 months&#xD;
             after the end of treatment&#xD;
&#xD;
          -  Subject (male or female) is not willing to use highly effective methods of&#xD;
             contraception (per institutional standard) during treatment and for 6 months (male or&#xD;
             female) after the end of treatment&#xD;
&#xD;
          -  Known hypersensitivity reaction to the component of the treatment&#xD;
&#xD;
          -  Active infection or malnutrition or bowel obstruction&#xD;
&#xD;
          -  Legal incapacity or limited legal capacity&#xD;
&#xD;
          -  Definite contraindications for the use of corticosteroids&#xD;
&#xD;
          -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or&#xD;
             evidence of interstitial lung disease on baseline chest CT scan&#xD;
&#xD;
          -  Chronic inflammation of the bowel&#xD;
&#xD;
          -  Clinically significant cardiovascular disease (including myocardial infarction,&#xD;
             unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac&#xD;
             arrhythmia) ≤ 1 year before enrollment&#xD;
&#xD;
          -  Medical or psychological condition which in the opinion of the investigator would not&#xD;
             permit the subject to complete the study or sign meaningful informed consent&#xD;
&#xD;
          -  Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Souglakos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Herklion</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vassilis Georgoulias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Heraklion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece</name>
      <address>
        <city>Heraklion</city>
        <state>Crete</state>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Laikon&quot; General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Air Forces Military Hospital of Athens Athens, Greece</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SOTIRIA Hospital, Medical Oncology Department</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Ag. Georgios&quot; General Hospital of Chania</name>
      <address>
        <city>Chania</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;PAPAGEORGIOY&quot; General Hospital of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>October 7, 2015</last_update_submitted>
  <last_update_submitted_qc>October 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Stomach</keyword>
  <keyword>Gastro-Esophageal Junction</keyword>
  <keyword>Salvage treatment</keyword>
  <keyword>Nab-paclitaxel</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</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/NCT02251951
org study id: CT/12.05
nct id: NCT02251951
lead sponsor: 
has dmc: No
The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II
      trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and
      gastro-esophageal junction
Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line
      chemotherapy are considered as an orphan disease with limited (if any) treatment options. The
      promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials
      conducted in breast cancer patients open the field to develop such therapeutic approaches in
      other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We
      design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage
      treatment for patients with advanced cancer of the stomach and GEJ previously treated with
      the DCF regimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate
time frame: Disease evaluation every 8 weeks up to 108 weeks
description: Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
measure: Disease control rate
time frame: Disease evaluation every 8 weeks up to 108 weeks
description: Documented disease control rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
measure: Progression Free Survival
time frame: Up to 108 weeks
description: From date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 108 weeks
measure: Overall Survival
time frame: Up to 108 weeks
description: From date of randomization until the date of last follow up or death from any cause, assessed up to 108 weeks
measure: Number of Participants with Adverse Events
time frame: Every two weeks up to 24 weeks
arm group label: nab-Paclitaxel
arm group type: Experimental
description: Abraxane
intervention type: Drug
intervention name: nab-Paclitaxel
description: Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d)
arm group label: nab-Paclitaxel
other name: Abraxane
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: John Souglakos, MD
role: Principal Investigator
affiliation: University Hospital of Herklion
last name: Vassilis Georgoulias, MD
role: Principal Investigator
affiliation: University Hospital of Heraklion
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Paclitaxel