<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/NCT03257033</url>
  </required_header>
  <id_info>
    <org_study_id>RR3 [CP-03-001]</org_study_id>
    <nct_id>NCT03257033</nct_id>
  </id_info>
  <brief_title>Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC</brief_title>
  <acronym>TIGeR-PaC</acronym>
  <official_title>Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a multi-center, un-blinded, randomized control study of subjects with locally&#xD;
      advanced pancreatic adenocarcinoma which is unresectable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as&#xD;
      radiation therapy for approximately four months. Subjects who remain eligible will then be&#xD;
      randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue&#xD;
      gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16&#xD;
      weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel&#xD;
      or oral capecitabine following the 16 week treatment course until disease progression at the&#xD;
      discretion of the Investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 12, 2018</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2022</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Subjects with stable or responding disease after approximately four months of induction therapy, and who are not surgical candidates will then be randomized to be in either the test group or control group. Crossovers are not allowed.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 Years</time_frame>
    <description>OS from time of randomization will be calculated using the Kaplan-Meier method and compared between the test and control groups using the stratified Log-Rank Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival for treatment received and unresected populations</measure>
    <time_frame>3 Years</time_frame>
    <description>The primary endpoint analysis will be repeated for the Treatment Received and Unresected Subject populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>3 Years</time_frame>
    <description>To compare the Progression Free Survival of intra-arterial delivery of gemcitabine using the RenovoCath™ device vs. continuation of IV gemcitabine and nab-paclitaxel following induction therapy with gemcitabine and nab-paclitaxel and radiation treatment for locally advanced pancreatic adenocarcinoma. Disease response and progression will be assessed according to RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate and duration of response</measure>
    <time_frame>3 Years</time_frame>
    <description>Objective response is defined as a complete response, CR, or partial response, PR, determined by Investigator assessment and confirmed by repeat assessment ≥ 4 weeks after initial documentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>3 Years</time_frame>
    <description>The EORTC questionnaire will be used to assess health related quality of life. The summary scores for the EORTC questionnaire will be calculated at baseline and follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy Assessment</measure>
    <time_frame>1 Year</time_frame>
    <description>The degree of neuropathy will be measured by the FACT/GOG-NTX-4 (version 4). The results will be cross tabulated by randomized treatment group for each study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of neutropenia</measure>
    <time_frame>1 Year</time_frame>
    <description>Neutropenia with onset after randomization requiring the use of filgrastim or other medications for white blood cell stimulation will be compared between the test and control groups through progression of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported symptoms</measure>
    <time_frame>3 years</time_frame>
    <description>Symptoms reported by subjects using the PRO-CTCAE questionnaire will be compared between the test and control groups through progression of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety, defined as adverse event rate, and tolerability, defined as occurrence of treatment discontinuation</measure>
    <time_frame>3 years</time_frame>
    <description>Safety and tolerability will be assessed by the occurrence of treatment discontinuation and the presence of adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Locally Advanced Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>IA Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Chemotherapy</description>
    <arm_group_label>IA Therapy</arm_group_label>
    <arm_group_label>IV Therapy</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nab-paclitaxel</intervention_name>
    <description>Chemotherapy</description>
    <arm_group_label>IV Therapy</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RenovoCath</intervention_name>
    <description>Intra-arterial catheter</description>
    <arm_group_label>IA Therapy</arm_group_label>
    <other_name>RenovoCath RC120</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial&#xD;
             diagnosis within 6 weeks of consent.&#xD;
&#xD;
          2. Locally advanced, unresectable disease at screening and prior to randomization, as&#xD;
             defined by NCCN criteria determined by an on-site, experienced, multidisciplinary team&#xD;
&#xD;
          3. ECOG performance status 0-1&#xD;
&#xD;
          4. Age ≥ 18 years&#xD;
&#xD;
          5. Adequate laboratory values prior to starting the first dose of nab-paclitaxel and&#xD;
             gemcitabine:&#xD;
&#xD;
               1. Absolute neutrophil count ≥ 1,500/μL&#xD;
&#xD;
               2. Platelet count ≥ 100,000/μL&#xD;
&#xD;
               3. Hemoglobin ≥ 9.0 g/dL&#xD;
&#xD;
               4. Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min/1.73 m2 for&#xD;
                  subjects with creatinine &gt;1.5 mg/dL&#xD;
&#xD;
               5. AST and ALT ≤ 3.0 X the upper normal limit of institution's normal range&#xD;
&#xD;
               6. Total bilirubin ≤ 1.5 X the upper normal limit of institution's normal range -OR-&#xD;
                  If biliary stent placed or planned to be placed within 6 weeks of Cycle 1 Day 1,&#xD;
                  total bilirubin ≤ 2.0 X the upper normal limit of institution's normal range&#xD;
&#xD;
               7. PT and PTT must be ≤ 1.5 X upper normal limit of institution's normal range&#xD;
&#xD;
               8. INR ≤ 1.5&#xD;
&#xD;
          6. Life expectancy &gt; 12 weeks&#xD;
&#xD;
          7. Negative pregnancy test for women of childbearing potential (either serum or urine)&#xD;
             within 1 day prior to administration of the first dose of chemotherapy. Women of&#xD;
             childbearing potential should only use highly effective methods of contraception&#xD;
             during treatment and for up to 6 months following treatment cessation.&#xD;
&#xD;
          8. Provide written informed consent&#xD;
&#xD;
          9. Subjects willing to participate in the study for at least 8 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any prior treatment for pancreatic cancer OR more than one cycle of gemcitabine and&#xD;
             nab-paclitaxel treatment. For subjects who have started on first cycle of gemcitabine&#xD;
             and nab-paclitaxel treatment prior to consent, Inclusion Criterion #1 only applies in&#xD;
             that the first gemcitabine and nab-paclitaxel dose must be within 6 weeks of confirmed&#xD;
             diagnosis.&#xD;
&#xD;
          2. Any evidence of metastatic disease or another active malignancy within the past one&#xD;
             year except for cervical cancer in situ, in situ carcinoma of the bladder or&#xD;
             non-melanoma carcinoma of the skin.&#xD;
&#xD;
          3. Subjects unable or unwilling to have their first randomized treatment within 3 weeks&#xD;
             of the post induction imaging and within 5 weeks of their last induction treatment&#xD;
&#xD;
          4. Subjects without baseline tumor imaging&#xD;
&#xD;
          5. To be determined by the sponsor and not by the site:&#xD;
&#xD;
             Arterial anatomy unsuitable for IA delivery of gemcitabine to the intended tumor site,&#xD;
             determined by CT or MRI, as determined and approved by the sponsor, which includes the&#xD;
             following:&#xD;
&#xD;
               1. Stenosis or occlusion in intended artery for treatment&#xD;
&#xD;
               2. Inability to exclude major side branches in the area of the intended RenovoCath®&#xD;
                  catheter occlusion&#xD;
&#xD;
               3. No suitable artery with a diameter greater than 3mm in proximity of at least one&#xD;
                  side of the tumor&#xD;
&#xD;
               4. Superior mesenteric vein occlusion or stenosis that cannot be resolved with&#xD;
                  medication or intervention prior to randomization, if the superior mesenteric&#xD;
                  artery is the only viable treatment artery Note: Arterial Anatomy will be&#xD;
                  reviewed by the core imaging lab, RenovoRx Imaging Advisor, and RenovoRx Medical&#xD;
                  Monitor for approval&#xD;
&#xD;
          6. Contraindications for SBRT planning which includes the following:&#xD;
&#xD;
               1. Gastrointestinal mucosal infiltration evident at the time of diagnostic endoscopy&#xD;
&#xD;
               2. Prior abdominal radiotherapy judged to have clinically significant degree of&#xD;
                  overlap with planned SBRT dose distribution Note: Primary tumors with a diameter&#xD;
                  greater than 7cm must be assessed on a case-by-case basis with the Central&#xD;
                  Radiation Reviewer prior to excluding patient from trial.&#xD;
&#xD;
          7. Subjects with known HIV or active viral hepatitis&#xD;
&#xD;
          8. Severe infections within 4 weeks prior to the first study treatment, including but not&#xD;
             limited to hospitalization for complications of infection, bacteremia or severe&#xD;
             pneumonia&#xD;
&#xD;
          9. Signs or symptoms of infection within 2 weeks prior to the first study treatment&#xD;
&#xD;
         10. Received oral or IV antibiotics for an infection within 2 weeks prior to the first&#xD;
             study treatment. Subjects receiving prophylactic antibiotics are eligible&#xD;
&#xD;
         11. History of severe allergic, anaphylactic, or other hypersensitivity reactions to&#xD;
             gemcitabine or nab-paclitaxel&#xD;
&#xD;
         12. Any anti-cancer therapy including chemotherapy, hormonal therapy, or radiotherapy&#xD;
             within 2 weeks prior to initiation of study treatment; or herbal therapy intended as&#xD;
             anti-cancer therapy within 1 week prior to initiation of study treatment&#xD;
&#xD;
         13. Subjects with uncontrolled seizures&#xD;
&#xD;
         14. Cardiovascular disease including unstable angina or life-threatening cardiac&#xD;
             arrhythmia, myocardial infarction, stroke; or NYHA Class III or IV congestive heart&#xD;
             failure within the last 3 months prior to the first study treatment. Subjects with&#xD;
             prior history of Myocardial Infarction, congestive heart failure, coronary artery&#xD;
             bypass grafting, or prior valve surgery need to have assessment of ejection fraction&#xD;
             to ensure EF is not ≤ 40% (based upon MRI, ECHO, or Nuclear Scan), within last 3&#xD;
             months prior to the first study treatment&#xD;
&#xD;
         15. Other severe concurrent disease, or comorbidities which make it difficult to&#xD;
             participate in this study.&#xD;
&#xD;
         16. Any of the following procedures prior to initiation of study treatment:&#xD;
&#xD;
               1. Catheterization, endoscopy, stent or drain placement, within 48 hours.&#xD;
                  (Diagnostic laparoscopy without surgical intervention and/or port placement do&#xD;
                  not require any wait time prior to study treatment.)&#xD;
&#xD;
               2. Minor surgery requiring light sedation (such as surgical laparoscopy) within 2&#xD;
                  weeks&#xD;
&#xD;
               3. Major surgery within 4 weeks&#xD;
&#xD;
         17. Women who are breastfeeding&#xD;
&#xD;
         18. Male or female subjects of reproductive potential who do not agree to either remain&#xD;
             abstinent or employ highly effective and acceptable forms of contraception throughout&#xD;
             their participation in the study and for 6 months after the last study treatment&#xD;
&#xD;
         19. Subjects receiving any other investigational agents within 2 weeks prior to the first&#xD;
             study treatment&#xD;
&#xD;
         20. Any social situations or psychiatric illness that would limit compliance with study&#xD;
             requirements&#xD;
&#xD;
         21. Subjects unable or unwilling to have standard catherization procedure&#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>Michael J Pishvaian</last_name>
    <role>Study Chair</role>
    <affiliation>Johns Hopkins Kimmel Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carter Hultman</last_name>
    <phone>6502844433</phone>
    <email>chultman@renovorx.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nicole G Lama</last_name>
    <phone>6502844433</phone>
    <email>nlama@renovorx.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA Loma Linda Healthcare System</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92357</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Sutter Cancer Center Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clara Dunn</last_name>
      <phone>916-454-6931</phone>
      <email>dunncm@sutterhealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Michele Pierini</last_name>
      <phone>916-454-6994</phone>
      <email>pierinmm@sutterhealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Christopher Laing, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Georgetown University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20057</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33907</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33167</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Priscilla Lopez</last_name>
      <phone>786-527-8561</phone>
      <email>PriscillaLop@BaptistHealth.net</email>
    </contact>
    <investigator>
      <last_name>Ripal Gandhi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antonio Ucar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Health Care System</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34329</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angele Price</last_name>
      <phone>941-917-3614</phone>
      <email>Angele-Price@smh.com</email>
    </contact>
    <investigator>
      <last_name>Kenneth Meredith, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cassie Angelo</last_name>
      <phone>813-745-4584</phone>
      <email>Cassie.Angelo@moffitt.org</email>
    </contact>
    <investigator>
      <last_name>Nainesh Parikh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ASCLEPES Research Centers</name>
      <address>
        <city>Weeki Wachee</city>
        <state>Florida</state>
        <zip>34607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Piedmont-Columbus Regional - John B. Amos Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michelle Arnold</last_name>
      <phone>319-356-2778</phone>
      <email>michelle-arnold@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>Pashtoon Kasi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>LSU Health Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Medstar Franklin Square</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21237</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Casey M O'Quinn</last_name>
      <phone>603-653-9338</phone>
      <email>Casey.M.O'Quinn@hitchcock.org</email>
    </contact>
    <investigator>
      <last_name>Eric Hoffer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center at Cooper Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Atlantic Health System - Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Albany Stratton VA Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Montefiore Hospital</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadine Kuriakose</last_name>
      <phone>212-304-5530</phone>
      <email>nk2947@cumc.columbia.edu</email>
    </contact>
    <investigator>
      <last_name>Susan Bates, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute - Atrium Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melani Terri, BSN</last_name>
      <phone>704-863-2318</phone>
      <email>melani.terry@atriumhealth.org</email>
    </contact>
    <investigator>
      <last_name>Reza Nazemzadeh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denise Brigham</last_name>
      <phone>252-744-4924</phone>
      <email>brighamd16@ecu.edu</email>
    </contact>
    <investigator>
      <last_name>Emmanuel Zervos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Comprehensive Cancer Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacie Moore</last_name>
      <phone>336-716-6694</phone>
      <email>snmoore@wakehealth.edu</email>
    </contact>
    <contact_backup>
      <last_name>Austin Humbert</last_name>
      <phone>336-713-6912</phone>
      <email>ahumbert@wakehealth.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Brian Kouri, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oklahoma University - Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Yarbrough</last_name>
      <phone>405-271-8001</phone>
      <phone_ext>48340</phone_ext>
      <email>melissa-yarbrough@ouhsc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Genie Bryant</last_name>
      <phone>(405) 271-8001</phone>
      <phone_ext>53482</phone_ext>
      <email>genie-bryant@ouhsc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Hassan Hatoum, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Knight Cancer Institute Clinical Trial Information</last_name>
      <phone>503-494-1080</phone>
    </contact>
    <investigator>
      <last_name>Charles Lopez, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wendy Lane-Scott</last_name>
      <phone>412-864-7688</phone>
      <email>lanewg@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Amer Zureikat, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina - Hollings Cancer Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsay Hunt</last_name>
      <phone>843-792-9778</phone>
      <email>winterl@musc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Alan Brisendine</last_name>
      <phone>843-792-9007</phone>
      <email>brisend@musc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>David T Johnson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health (formerly Greenville Health System)</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>West Virginia University Medicine</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabrina Martin-Vernon</last_name>
      <phone>304-581-1158</phone>
      <email>sabrina.martinvernon@hsc.wvu.edu</email>
    </contact>
    <investigator>
      <last_name>Brian Boone, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Lucas</name>
      <address>
        <city>Brugge</city>
        <zip>8310</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>UZ Antwerp</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Jolimont Hospital</name>
      <address>
        <city>La Louvière</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>AZ Delta</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2022</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>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>
  <!-- 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/NCT03257033
org study id: RR3 [CP-03-001]
nct id: NCT03257033
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: Yes
The study is a multi-center, un-blinded, randomized control study of subjects with locally
      advanced pancreatic adenocarcinoma which is unresectable.
All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as
      radiation therapy for approximately four months. Subjects who remain eligible will then be
      randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue
      gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16
      weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel
      or oral capecitabine following the 16 week treatment course until disease progression at the
      discretion of the Investigator.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects with stable or responding disease after approximately four months of induction therapy, and who are not surgical candidates will then be randomized to be in either the test group or control group. Crossovers are not allowed.
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: 3 Years
description: OS from time of randomization will be calculated using the Kaplan-Meier method and compared between the test and control groups using the stratified Log-Rank Test
measure: Overall Survival for treatment received and unresected populations
time frame: 3 Years
description: The primary endpoint analysis will be repeated for the Treatment Received and Unresected Subject populations.
measure: Progression Free Survival
time frame: 3 Years
description: To compare the Progression Free Survival of intra-arterial delivery of gemcitabine using the RenovoCath™ device vs. continuation of IV gemcitabine and nab-paclitaxel following induction therapy with gemcitabine and nab-paclitaxel and radiation treatment for locally advanced pancreatic adenocarcinoma. Disease response and progression will be assessed according to RECIST 1.1.
measure: Objective response rate and duration of response
time frame: 3 Years
description: Objective response is defined as a complete response, CR, or partial response, PR, determined by Investigator assessment and confirmed by repeat assessment ≥ 4 weeks after initial documentation.
measure: Health Related Quality of Life
time frame: 3 Years
description: The EORTC questionnaire will be used to assess health related quality of life. The summary scores for the EORTC questionnaire will be calculated at baseline and follow-up.
measure: Neuropathy Assessment
time frame: 1 Year
description: The degree of neuropathy will be measured by the FACT/GOG-NTX-4 (version 4). The results will be cross tabulated by randomized treatment group for each study visit.
measure: Frequency of neutropenia
time frame: 1 Year
description: Neutropenia with onset after randomization requiring the use of filgrastim or other medications for white blood cell stimulation will be compared between the test and control groups through progression of disease.
measure: Patient reported symptoms
time frame: 3 years
description: Symptoms reported by subjects using the PRO-CTCAE questionnaire will be compared between the test and control groups through progression of disease.
measure: Safety, defined as adverse event rate, and tolerability, defined as occurrence of treatment discontinuation
time frame: 3 years
description: Safety and tolerability will be assessed by the occurrence of treatment discontinuation and the presence of adverse events
arm group label: IA Therapy
arm group type: Experimental
description: IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.
arm group label: IV Therapy
arm group type: Active Comparator
description: IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes.
intervention type: Drug
intervention name: Gemcitabine
description: Chemotherapy
arm group label: IA Therapy
arm group label: IV Therapy
other name: Gemzar
intervention type: Drug
intervention name: nab-paclitaxel
description: Chemotherapy
arm group label: IV Therapy
other name: Abraxane
intervention type: Device
intervention name: RenovoCath
description: Intra-arterial catheter
arm group label: IA Therapy
other name: RenovoCath RC120
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael J Pishvaian
role: Study Chair
affiliation: Johns Hopkins Kimmel Cancer Center
last name: Carter Hultman
phone: 6502844433
email: chultman@renovorx.com
last name: Nicole G Lama
phone: 6502844433
email: nlama@renovorx.com
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Terminated
country: Belgium
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Paclitaxel
mesh term: Gemcitabine