<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/NCT02210364</url>
  </required_header>
  <id_info>
    <org_study_id>PM1183-A-006-12</org_study_id>
    <nct_id>NCT02210364</nct_id>
  </id_info>
  <brief_title>Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).</brief_title>
  <official_title>Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PharmaMar</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PharmaMar</source>
  <brief_summary>
    <textblock>
      Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin&#xD;
      (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast&#xD;
      Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the&#xD;
      recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety&#xD;
      profile, to explore the feasibility of PM01183 dose optimization, to characterize the&#xD;
      pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity&#xD;
      of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recommended dose of PM01183 in combination with capecitabine</measure>
    <time_frame>30 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>lurbinectedin (PM01183) and capecitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lurbinectedin (PM01183)</intervention_name>
    <description>lurbinectedin (PM01183) 1 mg and 4 mg vials</description>
    <arm_group_label>lurbinectedin (PM01183) and capecitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>capecitabine</intervention_name>
    <description>capecitabine 150 mg tablets</description>
    <arm_group_label>lurbinectedin (PM01183) and capecitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Voluntarily signed and dated written informed consent (IC)&#xD;
&#xD;
          -  Age between 18 and 75 years&#xD;
&#xD;
          -  Women of childbearing potential must have pregnancy excluded by appropriate testing&#xD;
             before study entry.&#xD;
&#xD;
          -  Life expectancy ≥ 3 months.&#xD;
&#xD;
          -  Patients with a histologically/cytologically confirmed diagnosis of unresectable&#xD;
             Metastatic Breast Cancer, Pancreatic Cancer or metastatic Colorectal Cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Three or more prior chemotherapy-containing lines for advanced disease.&#xD;
&#xD;
          -  Prior treatment with PM01183 or with capecitabine containing therapy for advanced&#xD;
             disease.&#xD;
&#xD;
          -  History within the last year or presence of unstable angina, myocardial infarction,&#xD;
             congestive heart failure, or clinically relevant valvular heart disease or symptomatic&#xD;
             arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment.&#xD;
&#xD;
          -  Ongoing chronic hepatopathy of any origin.&#xD;
&#xD;
          -  Active uncontrolled infection.&#xD;
&#xD;
          -  Patients with dyspnea who are requiring any ongoing oxygen support.&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  Any other major illness that, in the Investigator's judgment, will substantially&#xD;
             increase the risk associated with the patient's participation in this study.&#xD;
&#xD;
          -  Men or women of childbearing potential who are not using an effective method of&#xD;
             contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</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>Breast Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</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/NCT02210364
org study id: PM1183-A-006-12
nct id: NCT02210364
lead sponsor: 
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin
      (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast
      Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the
      recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety
      profile, to explore the feasibility of PM01183 dose optimization, to characterize the
      pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity
      of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recommended dose of PM01183 in combination with capecitabine
time frame: 30 months
arm group label: lurbinectedin (PM01183) and capecitabine
arm group type: Experimental
intervention type: Drug
intervention name: lurbinectedin (PM01183)
description: lurbinectedin (PM01183) 1 mg and 4 mg vials
arm group label: lurbinectedin (PM01183) and capecitabine
intervention type: Drug
intervention name: capecitabine
description: capecitabine 150 mg tablets
arm group label: lurbinectedin (PM01183) and capecitabine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
country: Belgium
country: Spain
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Pancreatic Neoplasms
mesh term: Capecitabine