<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/NCT03300921</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC 26217</org_study_id>
    <nct_id>NCT03300921</nct_id>
  </id_info>
  <brief_title>A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer</brief_title>
  <official_title>A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to look at the potential effects of paricalcitol (a drug&#xD;
      similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal&#xD;
      of their tumor. The study will also look at the safety of paricalcitol prior to surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Newer research suggested that paricalcitol may be harmful to a subset of pancreatic cancer&#xD;
    patients and it is not feasible to subtype patients in the short time frame before surgery&#xD;
  </why_stopped>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">March 23, 2022</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Arm A: 50mcg IV weekly Arm B: 12mcg PO daily</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A: 50mcg IV weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm B: 12mcg PO daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paricalcitol</intervention_name>
    <description>Product: Paricalcitol&#xD;
Dose/Route/Regimen:&#xD;
Arm A: 50mcg IV weekly Arm B: 12mcg PO daily</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously untreated, apparently resectable, adenocarcinoma of the pancreas at&#xD;
             registration.&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Medically fit for surgery in the opinion of the treating surgeon&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients who are currently pregnant, planning to become pregnant, or breast-feeding.&#xD;
&#xD;
        Note: women of childbearing potential must agree to use a medically accepted form of birth&#xD;
        control including (condoms, diaphragms, cervical cap, an intra-uterine device (IUD),&#xD;
        surgical sterility [tubal ligation or a partner that has undergone a vasectomy], or oral&#xD;
        contraceptives). OR must agree to completely abstain from intercourse for two weeks before&#xD;
        beginning study treatment, during participation in this study, and for 2 weeks after the&#xD;
        final study treatment&#xD;
&#xD;
          -  Patients with hypercalcemia (blood levels greater than 11.5 mg/dL). Note: In patients&#xD;
             with GFR 30-60 mL/min by Cockroft-Gault, blood calcium levels must be 9.5 mg/dL or&#xD;
             lower before starting paricalcitol.&#xD;
&#xD;
          -  Serum creatinine &gt; 2.5 x ULN OR GFR &lt;30 mL/min by Cockroft-Gault formula . Patients&#xD;
             who, in the opinion of the physician, would not be clinically appropriate for receipt&#xD;
             of the therapy regimen associated with participation.&#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>Peter O'Dwyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abramson Cancer Center at Penn Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abramson Cancer Center of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 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>
  <!-- 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/NCT03300921
org study id: UPCC 26217
nct id: NCT03300921
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to look at the potential effects of paricalcitol (a drug
      similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal
      of their tumor. The study will also look at the safety of paricalcitol prior to surgery.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Adverse Events
time frame: 18 months
arm group label: Arm A
arm group type: Experimental
description: Arm A: 50mcg IV weekly
arm group label: Arm B
arm group type: Experimental
description: Arm B: 12mcg PO daily
intervention type: Drug
intervention name: Paricalcitol
description: Product: Paricalcitol
Dose/Route/Regimen:
Arm A: 50mcg IV weekly Arm B: 12mcg PO daily
arm group label: Arm A
arm group label: Arm B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter O'Dwyer, MD
role: Principal Investigator
affiliation: Abramson Cancer Center at Penn Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms