<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/NCT03756311</url>
  </required_header>
  <id_info>
    <org_study_id>NANOPAC-EA</org_study_id>
    <nct_id>NCT03756311</nct_id>
  </id_info>
  <brief_title>Expanded Access to NanoPac</brief_title>
  <official_title>Expanded Access to NanoPac</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NanOlogy, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Biotest, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NanOlogy, LLC</source>
  <brief_summary>
    <textblock>
      NanOlogy may consider offering expanded access to NanoPac for patients who do not meet the&#xD;
      enrollment criteria of clinical trials in progress.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension</intervention_name>
    <other_name>Paclitaxel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Gere diZerega, MD</last_name>
    <phone>805-595-1300</phone>
    <email>gere.dizerega@usbiotest.com</email>
  </overall_contact>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>April 7, 2022</last_update_submitted>
  <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03756311
org study id: NANOPAC-EA
nct id: NCT03756311
lead sponsor: 
collaborator: 
NanOlogy may consider offering expanded access to NanoPac for patients who do not meet the
      enrollment criteria of clinical trials in progress.
expanded access type individual: Yes
intervention type: Drug
intervention name: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
other name: Paclitaxel
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Gere diZerega, MD
phone: 805-595-1300
email: gere.dizerega@usbiotest.com
responsible party type: Sponsor
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel