<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/NCT03807999</url>
  </required_header>
  <id_info>
    <org_study_id>AX-PANC-SY001</org_study_id>
    <nct_id>NCT03807999</nct_id>
  </id_info>
  <brief_title>Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer</brief_title>
  <official_title>Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Metastatic or Locally Advanced Unresectable Adenocarcinoma of The Pancreas: A Phase II Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or&#xD;
      gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or&#xD;
      metastatic pancreatic cancer.&#xD;
&#xD;
      Arm 1: Nab-paclitaxel plus gemcitabine Arm 2: Gemcitabine alone&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or&#xD;
      gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or&#xD;
      metastatic pancreatic cancer.&#xD;
&#xD;
      Arm 1: Nab-paclitaxel plus gemcitabine Arm 2: Gemcitabine alone&#xD;
&#xD;
      Arm 1:&#xD;
&#xD;
      Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40&#xD;
      minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a&#xD;
      30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of&#xD;
      rest.&#xD;
&#xD;
      OR&#xD;
&#xD;
      Arm 2:&#xD;
&#xD;
      Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered&#xD;
      weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by&#xD;
      cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of&#xD;
      rest (4-week cycle).&#xD;
&#xD;
      All patients will be considered for available second-line therapies or best supportive care&#xD;
      on the discretion of the investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2015</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-months deterioration-free rate</measure>
    <time_frame>From first dose of therapy to third month of therapy, 3 months</time_frame>
    <description>EORTC QLQ-C30 (validated version for Turkish using a reduction of at least 10 points as a meaningful clinical difference) will be used to calculate &quot;time until definitive deterioration&quot; (TUDD) and compare patients receiving first-line Nab-Paclitaxel plus Gemcitabine versus first-line gemcitabine for metastatic or locally advanced unresectable adenocarcinoma of the pancreas. EORTC QLQ-C30 scores will be calculated every four weeks following the EORTC QLQ-C30 recommendations for calculations and scoring (EORTC QLQ- C30 published manual).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From first dose to death or end of the therapy, 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Pancreatic Neoplasm</condition>
  <arm_group>
    <arm_group_label>Nab-paclitaxel + Gemcitabine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of rest.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel</intervention_name>
    <arm_group_label>Nab-paclitaxel + Gemcitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <arm_group_label>Gemcitabine</arm_group_label>
    <arm_group_label>Nab-paclitaxel + Gemcitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent.&#xD;
&#xD;
          2. Histologically or cytologically confirmed treatment-naïve metastatic or locally&#xD;
             advanced adenocarcinoma of the pancreas not amenable to curative radiotherapy or&#xD;
             surgery.&#xD;
&#xD;
          3. Measurable disease as defined by RECIST (ie, target lesions that can be accurately&#xD;
             measured in at least one dimension with the longest diameter ≥ 20 mm using&#xD;
             conventional techniques or ≥ 10 mm using spiral computed tomography [CT] scan).&#xD;
&#xD;
          4. Age ≥ 18 years.&#xD;
&#xD;
          5. ECOG Performance Status 0 or 1.&#xD;
&#xD;
          6. Adequate bone marrow function: granulocyte count ≥1500 and platelet count ≥100,000 per&#xD;
             cubic millimeter.&#xD;
&#xD;
          7. Adequate liver function as defined by the following criteria:&#xD;
&#xD;
               -  Total serum bilirubin &lt;2 mg/dl.&#xD;
&#xD;
               -  ALP/GGT &lt;5 x ULN.&#xD;
&#xD;
               -  Transaminases ALT/AST ≤ 2.5 x ULN.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any prior systemic or investigational therapy for metastatic pancreatic cancer.&#xD;
             Systemic therapy administered alone or in combination with radiation in the adjuvant&#xD;
             setting is permitted if it is completed &gt; 6 months prior to the time of study&#xD;
             enrollment.&#xD;
&#xD;
          2. Inability to comply with study and/or follow-up procedures.&#xD;
&#xD;
          3. Presence of significant comorbidity including clinically significant cardiac disease&#xD;
             (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac&#xD;
             arrhythmias not well controlled with medication) or myocardial infarction within the&#xD;
             last 12 months and any other major organ failure.&#xD;
&#xD;
          4. Presence of any condition that, in the opinion of the investigator, renders the&#xD;
             subject at high risk from treatment complications or might affect the interpretation&#xD;
             of the results of the study.&#xD;
&#xD;
          5. Presence of central nervous system or brain metastases.&#xD;
&#xD;
          6. Life expectancy &lt;12 weeks.&#xD;
&#xD;
          7. Pregnancy (positive pregnancy test) or lactation.&#xD;
&#xD;
          8. Prior malignancy except for adequately treated basal cell skin cancer, in situ&#xD;
             cervical cancer, adequately treated Stage I or II cancer from which the patient is&#xD;
             currently in complete remission, or any other form of cancer from which the patient&#xD;
             has been disease-free for 5 years.&#xD;
&#xD;
          9. Lack of physical integrity of the upper gastrointestinal tract or malabsorption&#xD;
             syndrome.&#xD;
&#xD;
         10. Known, existing uncontrolled coagulopathy.&#xD;
&#xD;
         11. Pre-existing sensory neuropathy &gt; grade 1.&#xD;
&#xD;
         12. Major surgery within 4 weeks of the start of study treatment, without complete&#xD;
             recovery.&#xD;
&#xD;
         13. Concurrent/pre-existing use of coumadin. 14. Patients older than 76 years of age.&#xD;
&#xD;
        15. Patients with active infection. 16. Patients with chronic diarrhea.&#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>Suayib Yalcin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Suayib Yalcin</investigator_full_name>
    <investigator_title>Prof. Suayib Yalcin</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic 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>Gemcitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 7, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03807999/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03807999
org study id: AX-PANC-SY001
nct id: NCT03807999
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or
      gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or
      metastatic pancreatic cancer.

      Arm 1: Nab-paclitaxel plus gemcitabine Arm 2: Gemcitabine alone
This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or
      gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or
      metastatic pancreatic cancer.

      Arm 1: Nab-paclitaxel plus gemcitabine Arm 2: Gemcitabine alone

      Arm 1:

      Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40
      minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a
      30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of
      rest.

      OR

      Arm 2:

      Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered
      weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by
      cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of
      rest (4-week cycle).

      All patients will be considered for available second-line therapies or best supportive care
      on the discretion of the investigators.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-months deterioration-free rate
time frame: From first dose of therapy to third month of therapy, 3 months
description: EORTC QLQ-C30 (validated version for Turkish using a reduction of at least 10 points as a meaningful clinical difference) will be used to calculate "time until definitive deterioration" (TUDD) and compare patients receiving first-line Nab-Paclitaxel plus Gemcitabine versus first-line gemcitabine for metastatic or locally advanced unresectable adenocarcinoma of the pancreas. EORTC QLQ-C30 scores will be calculated every four weeks following the EORTC QLQ-C30 recommendations for calculations and scoring (EORTC QLQ- C30 published manual).
measure: Overall Survival
time frame: From first dose to death or end of the therapy, 24 months
arm group label: Nab-paclitaxel + Gemcitabine
arm group type: Active Comparator
description: Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of rest.
arm group label: Gemcitabine
arm group type: Experimental
description: Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).
intervention type: Drug
intervention name: Nab-paclitaxel
arm group label: Nab-paclitaxel + Gemcitabine
intervention type: Drug
intervention name: Gemcitabine
arm group label: Gemcitabine
arm group label: Nab-paclitaxel + Gemcitabine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suayib Yalcin
role: Principal Investigator
affiliation: Hacettepe University
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Suayib Yalcin
investigator title: Prof. Suayib Yalcin
mesh term: Pancreatic Neoplasms
mesh term: Paclitaxel
mesh term: Gemcitabine
sharing ipd: Undecided
provided document: 