<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/NCT01668108</url>
  </required_header>
  <id_info>
    <org_study_id>ONKOPAC 01</org_study_id>
    <nct_id>NCT01668108</nct_id>
  </id_info>
  <brief_title>A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer</brief_title>
  <official_title>Open, Multicenter Observational Study of Paclitaxel Utilized in Mono- or Combination Therapy for the Treatment of Breast Cancer, Non-small Cell Lung Cancer and Ovarial Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Onkovis GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AKP Freiburg GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Onkovis GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this observational study with Paclitaxel is to determine the number of&#xD;
      treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special&#xD;
      circumstance of ambulant chemotherapy.&#xD;
&#xD;
      onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted&#xD;
      packaging sizes as to decrease the excess quantity to be discarded follows also this&#xD;
      objective.&#xD;
&#xD;
      Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison&#xD;
      to Docetaxel. To this purpose, data regarding co medications and adverse events are also&#xD;
      collected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the quantity of Paclitaxel onkovis needed pro treatment cycle</measure>
    <time_frame>the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles).</time_frame>
    <description>Determine the quantity of Paclitaxel onkovis needed pro treatment cycle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events during and after treatment in comparison to Docetaxel onkovis</measure>
    <time_frame>up to 24 weeks (8 cycles)</time_frame>
    <description>The number and kind of adverse events during and after the intra-venous application of Paclitaxel will be assessed, documented and compared to those of Docetaxel.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">770</enrollment>
  <condition>Carcinoma</condition>
  <arm_group>
    <arm_group_label>carcinoma, Paclitaxel onkovis (Paclitaxel)</arm_group_label>
    <description>treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- and ovarial cancer.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated in practices, clinics, hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for Paclitaxel according to the SmPC and treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  according to the Paclitaxel SmPC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Brandenburg</city>
        <zip>14770</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Chemnitz</city>
        <zip>09117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Mühlhausen</city>
        <zip>99974</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Plauen</city>
        <zip>08525</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>carcinoma</keyword>
  <keyword>breast cancer</keyword>
  <keyword>non-small cell lung cancer</keyword>
  <keyword>ovarial cancer</keyword>
  <keyword>ambulant chemotherapy</keyword>
  <keyword>treatment cycles</keyword>
  <keyword>Paclitaxel</keyword>
  <keyword>Paclitaxel onkovis</keyword>
  <keyword>Quantity of Paclitaxel</keyword>
  <keyword>Packaging Sizes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</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/NCT01668108
org study id: ONKOPAC 01
nct id: NCT01668108
lead sponsor: 
collaborator: 
has dmc: No
The main purpose of this observational study with Paclitaxel is to determine the number of
      treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special
      circumstance of ambulant chemotherapy.

      onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted
      packaging sizes as to decrease the excess quantity to be discarded follows also this
      objective.

      Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison
      to Docetaxel. To this purpose, data regarding co medications and adverse events are also
      collected.
observational model: Other
time perspective: Prospective
measure: the quantity of Paclitaxel onkovis needed pro treatment cycle
time frame: the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles).
description: Determine the quantity of Paclitaxel onkovis needed pro treatment cycle
measure: adverse events during and after treatment in comparison to Docetaxel onkovis
time frame: up to 24 weeks (8 cycles)
description: The number and kind of adverse events during and after the intra-venous application of Paclitaxel will be assessed, documented and compared to those of Docetaxel.
arm group label: carcinoma, Paclitaxel onkovis (Paclitaxel)
description: treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- and ovarial cancer.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Carcinoma