<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/NCT02237157</url>
  </required_header>
  <id_info>
    <org_study_id>RR1</org_study_id>
    <nct_id>NCT02237157</nct_id>
  </id_info>
  <brief_title>A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer</brief_title>
  <official_title>A Dose Escalation Safety Study of Locally-Delivered (Intra-Arterial) Gemcitabine in Unresectable Adenocarcinoma of the Pancreas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenovoRx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenovoRx</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the&#xD;
      pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients diagnosed with unresectable pancreatic cancer who may or may not have had prior&#xD;
      chemotherapy or radiation therapy may be eligible to enroll in this dose escalation study to&#xD;
      determine the maximum tolerated dose of gemcitabine to be delivered locally to the pancreatic&#xD;
      tumors using the RenovoCath R120 catheter. Patients enrolled may receive up to 8&#xD;
      catheterizations for delivering gemcitabine directly to the pancreatic tumors starting at a&#xD;
      reduced dose( 1/4 of standard i.v. gemcitabine dose), then every two doses, increase the dose&#xD;
      by 25% if there are no toxicities up to a maximum dose of 1000 mg/m2. There are four cycles,&#xD;
      with two doses per cycle. Imaging studies will be conducted as well as assessment for&#xD;
      standard, myelosuppresive and gastric toxicities will be assessed. Pain will also be measured&#xD;
      throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Subjects receive a gradual increase of drug dose, until the full systemic dose is administered. Cycle 1: 250mg/m2. Cycle 2: 500mg/m2. Cycle 3: 750mg/m2. Cycle 4: 1000mg/m2.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas</measure>
    <time_frame>1 week post treatment</time_frame>
    <description>Maximum Tolerated Dose (MTD) of gemcitabine administered intra-arterially to the pancreatic tumor(s) using the RenovoCath™ RC120 catheter.&#xD;
One week post treatment, toxicities will be assessed to determine if there is a pre-defined Dose Limiting Toxicity necessitating dose stopping or holding.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CA19-9 Tumor Reduction</measure>
    <time_frame>1 week after treatment</time_frame>
    <description>Measurements of CA19-9 tumor marker are measured pre-treatment and at various time points (starting with one week) post treatment.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Gemcitabine, Local Delivery (Dose 1)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gemcitabine, Local Delivery (Dose 2)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gemcitabine, Local Delivery (Dose 3)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gemcitabine, Local Delivery (Dose 4)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine, local delivery</intervention_name>
    <description>Intra-arterial targeted drug delivery</description>
    <arm_group_label>Gemcitabine, Local Delivery (Dose 1)</arm_group_label>
    <arm_group_label>Gemcitabine, Local Delivery (Dose 2)</arm_group_label>
    <arm_group_label>Gemcitabine, Local Delivery (Dose 3)</arm_group_label>
    <arm_group_label>Gemcitabine, Local Delivery (Dose 4)</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects will be eligible to participate in the study if all of the following criteria are&#xD;
        met:&#xD;
&#xD;
          1. Males and female subjects 18 years of age and older.&#xD;
&#xD;
          2. Subjects with locally advanced unresectable adenocarcinoma (cytological or histologic&#xD;
             proof required) of the pancreas.. Patients with islet cell tumors are not eligible.&#xD;
&#xD;
          3. No clinical evidence of distant metastases, excluding single liver metastasis and&#xD;
             local lymph node involvement. Patients with more than a single liver metastasis and/or&#xD;
             other metastases who have already failed systemic chemotherapy and/or are on a break&#xD;
             from systemic chemotherapy who are not surgical candidates can also qualify for this&#xD;
             study.&#xD;
&#xD;
          4. Karnofsky Performance Status (KPS) &gt;60.&#xD;
&#xD;
          5. Adequate renal, and bone marrow function described as:&#xD;
&#xD;
               1. Leukocytes ≥ 3,000/uL&#xD;
&#xD;
               2. Absolute neutrophil count ≥ 1,500/uL&#xD;
&#xD;
               3. Platelets ≥100,000/uL&#xD;
&#xD;
               4. Serum creatinine ≥2.0 mg/dL. Creatinine less than or equal to 1.5 mg/dL or&#xD;
                  creatinine clearance greater than 40 mL/min/1.73 m2 for patients with creatinine&#xD;
                  levels above institutional normal, as calculated by the Cockcroft Gault formula.&#xD;
&#xD;
               5. Hemoglobin ≥8.5 g/dL (may be receiving supportive therapy)&#xD;
&#xD;
               6. PT/PTT (WNL)&#xD;
&#xD;
          6. Adequate Hepatic function (endoscopic or percutaneous drainage as needed) described&#xD;
             as:&#xD;
&#xD;
               1. Total bilirubin ≤3 times UNL (less than or equal to 2 mg/dL)&#xD;
&#xD;
               2. AST (SGOT)/ALT (SGPT) ≤ 5 times ULN or ≤5 times ULN in the setting of liver&#xD;
                  metastases.&#xD;
&#xD;
               3. Lipase and Amylase within normal limits.&#xD;
&#xD;
          7. Capable of understanding the purpose and risks of the study and willing to provide&#xD;
             written informed consent and to comply with the procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from participation in the study if any of the following criteria&#xD;
        are met:&#xD;
&#xD;
          1. Have a known sensitivity to gemcitabine.&#xD;
&#xD;
          2. Identification of metastatic disease, with the exception of single liver metastases or&#xD;
             local lymph node involvement. Patients with more than a single liver metastasis and/or&#xD;
             other metastases who have already failed systemic chemotherapy and/or are on a break&#xD;
             from systemic chemotherapy who are not surgical candidates can also qualify for this&#xD;
             study.&#xD;
&#xD;
          3. Evidence of coagulopathy.&#xD;
&#xD;
          4. Inability or unwillingness to comply with study procedures and/or follow-up&#xD;
             procedures.&#xD;
&#xD;
          5. Evidence of infection or other coexisting medical condition, which in the opinion of&#xD;
             the investigator would preclude administration of gemcitabine.&#xD;
&#xD;
          6. Patients with uncontrolled congestive heart failure, unstable angina and myocardial&#xD;
             infarction within 3 months.&#xD;
&#xD;
          7. Female patient who is pregnant, nursing or planning on becoming pregnant.&#xD;
&#xD;
          8. Current enrollment and participation in another clinical study or prior exposure to an&#xD;
             investigational agent within 12 weeks or 5 half-lives (whichever is longer) of&#xD;
             anticipated dosing on Day 1 of this study.&#xD;
&#xD;
          9. Have known brain metastases.&#xD;
&#xD;
         10. Have had any major surgery within four weeks of enrollment.&#xD;
&#xD;
         11. Have any clinically detectable ascites.&#xD;
&#xD;
         12. Have uncontrolled concomitant illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac&#xD;
             arrhythmia.&#xD;
&#xD;
         13. Have serious medical or psychiatric illness that could, in the Investigator's opinion,&#xD;
             potentially interfere with the completion of treatment according to this protocol.&#xD;
&#xD;
         14. Other invasive malignancies within the past 3 years (with the exception of&#xD;
             non-melanoma skin cancers, non-invasive bladder cancer or prostate cancer) not&#xD;
             approved by the Medical Monitor (contact MM in event of prior diagnosis with&#xD;
             malignancy to discuss enrollment status).&#xD;
&#xD;
         15. Have had any chemotherapy or systemic corticosteroids within 2 weeks of study entry.&#xD;
&#xD;
         16. Have acquired, hereditary or congenital immunodeficiency's including cellular&#xD;
             immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia or hepatitis.&#xD;
&#xD;
         17. Have a prior history of a documented hemolytic event.&#xD;
&#xD;
         18. Is HIV-positive or Hepatitis positive.&#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>Jiali Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>El Camino Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>El Camino Hospital, Oncology</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <results_first_submitted>December 6, 2018</results_first_submitted>
  <results_first_submitted_qc>April 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 7, 2021</results_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pancreatic cancer</keyword>
  <keyword>unresectable</keyword>
  <keyword>gemcitabine</keyword>
  <keyword>device</keyword>
  <keyword>local delivery</keyword>
  <keyword>chemoembolization</keyword>
  <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>Gemcitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Subjects who complete a cycle (&quot;arm&quot;/&quot;period&quot;) then proceed to receive the next higher dose.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Gemcitabine, Local Delivery (Dose 1)</title>
          <description>Gemcitabine; 1 cycles, two doses per cycle; 250mg/m2 dose&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
        </group>
        <group group_id="P2">
          <title>Gemcitabine, Local Delivery (Dose 2)</title>
          <description>Gemcitabine; 1 cycles, two doses per cycle; 500mg/m2 dose&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
        </group>
        <group group_id="P3">
          <title>Gemcitabine, Local Delivery (Dose 3)</title>
          <description>Gemcitabine; 1 cycles, two doses per cycle; 750mg/m2 dose&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
        </group>
        <group group_id="P4">
          <title>Gemcitabine, Local Delivery (Dose 4)</title>
          <description>Gemcitabine; 1 cycles, two doses per cycle; 1000mg/m2 dose&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Gemcitabine, Local Delivery (Dose 1)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Gemcitabine, Local Delivery (Dose 2)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Gemcitabine, Local Delivery (Dose 3)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Gemcitabine, Local Delivery (Dose 4)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Gemcitabine, Local Delivery</title>
          <description>Gemcitabine; 4 cycles, two doses per cycle; dose escalation&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.5" spread="9.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas</title>
        <description>Maximum Tolerated Dose (MTD) of gemcitabine administered intra-arterially to the pancreatic tumor(s) using the RenovoCath™ RC120 catheter.&#xD;
One week post treatment, toxicities will be assessed to determine if there is a pre-defined Dose Limiting Toxicity necessitating dose stopping or holding.</description>
        <time_frame>1 week post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gemcitabine, Local Delivery</title>
            <description>Gemcitabine; 4 cycles, two doses per cycle; dose escalation&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
          </group>
        </group_list>
        <measure>
          <title>Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas</title>
          <description>Maximum Tolerated Dose (MTD) of gemcitabine administered intra-arterially to the pancreatic tumor(s) using the RenovoCath™ RC120 catheter.&#xD;
One week post treatment, toxicities will be assessed to determine if there is a pre-defined Dose Limiting Toxicity necessitating dose stopping or holding.</description>
          <units>mg/m^2</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CA19-9 Tumor Reduction</title>
        <description>Measurements of CA19-9 tumor marker are measured pre-treatment and at various time points (starting with one week) post treatment.</description>
        <time_frame>1 week after treatment</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during the treatment period, an average of 2.5 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Gemcitabine, Local Delivery (Dose 1)</title>
          <description>Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
        </group>
        <group group_id="E2">
          <title>Gemcitabine, Local Delivery (Dose 2)</title>
          <description>Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
        </group>
        <group group_id="E3">
          <title>Gemcitabine, Local Delivery (Dose 3)</title>
          <description>Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
        </group>
        <group group_id="E4">
          <title>Gemcitabine, Local Delivery (Dose 4)</title>
          <description>Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose&#xD;
Gemcitabine, local delivery: Intra-arterial targeted drug delivery</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pain - Abdominal (NOS)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Duodenal Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Intraoperative Arterial Injury / Dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Intraoperative Arterial Injury - Lower Extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Intraoperative arterial injury - lower extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Intraoperative arterial injury - pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Median arcuate ligament syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial spasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vasovagal episode</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Charles Li</name_or_title>
      <organization>RenovoRx</organization>
      <phone>(650) 284-4433</phone>
      <email>charles@renovorx.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02237157
org study id: RR1
nct id: NCT02237157
lead sponsor: 
has dmc: Yes
A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the
      pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.
Patients diagnosed with unresectable pancreatic cancer who may or may not have had prior
      chemotherapy or radiation therapy may be eligible to enroll in this dose escalation study to
      determine the maximum tolerated dose of gemcitabine to be delivered locally to the pancreatic
      tumors using the RenovoCath R120 catheter. Patients enrolled may receive up to 8
      catheterizations for delivering gemcitabine directly to the pancreatic tumors starting at a
      reduced dose( 1/4 of standard i.v. gemcitabine dose), then every two doses, increase the dose
      by 25% if there are no toxicities up to a maximum dose of 1000 mg/m2. There are four cycles,
      with two doses per cycle. Imaging studies will be conducted as well as assessment for
      standard, myelosuppresive and gastric toxicities will be assessed. Pain will also be measured
      throughout the study.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Subjects receive a gradual increase of drug dose, until the full systemic dose is administered. Cycle 1: 250mg/m2. Cycle 2: 500mg/m2. Cycle 3: 750mg/m2. Cycle 4: 1000mg/m2.
primary purpose: Other
masking: None (Open Label)
measure: Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas
time frame: 1 week post treatment
description: Maximum Tolerated Dose (MTD) of gemcitabine administered intra-arterially to the pancreatic tumor(s) using the RenovoCath™ RC120 catheter.
One week post treatment, toxicities will be assessed to determine if there is a pre-defined Dose Limiting Toxicity necessitating dose stopping or holding.
measure: CA19-9 Tumor Reduction
time frame: 1 week after treatment
description: Measurements of CA19-9 tumor marker are measured pre-treatment and at various time points (starting with one week) post treatment.
arm group label: Gemcitabine, Local Delivery (Dose 1)
arm group type: Other
description: Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose
arm group label: Gemcitabine, Local Delivery (Dose 2)
arm group type: Other
description: Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose
arm group label: Gemcitabine, Local Delivery (Dose 3)
arm group type: Other
description: Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose
arm group label: Gemcitabine, Local Delivery (Dose 4)
arm group type: Other
description: Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose
intervention type: Drug
intervention name: Gemcitabine, local delivery
description: Intra-arterial targeted drug delivery
arm group label: Gemcitabine, Local Delivery (Dose 1)
arm group label: Gemcitabine, Local Delivery (Dose 2)
arm group label: Gemcitabine, Local Delivery (Dose 3)
arm group label: Gemcitabine, Local Delivery (Dose 4)
other name: Gemzar
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jiali Li, MD
role: Principal Investigator
affiliation: El Camino Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Gemcitabine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 