<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/NCT01695590</url>
  </required_header>
  <id_info>
    <org_study_id>PRLX93936-0002</org_study_id>
    <nct_id>NCT01695590</nct_id>
  </id_info>
  <brief_title>Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma</brief_title>
  <official_title>Phase 1/2, Multi-center, Open Label, Dose Escalation, Safety, Efficacy and PK Study of PRLX 93936 Administered IV 3 Days a Week for 3 Weeks Followed by a 9 Day Rest Period in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prolexys Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prolexys Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for&#xD;
      patients with relapsed or relapsed/refractory multiple myeloma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of&#xD;
           PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks&#xD;
           followed by a 9 day rest period, as treatment for patients with relapsed or&#xD;
           relapsed/refractory multiple myeloma.&#xD;
&#xD;
        -  To establish the dose of PRLX 93936 recommended for future studies.&#xD;
&#xD;
        -  To characterize potential toxicities of PRLX 93936.&#xD;
&#xD;
        -  To assess the pharmacokinetic profile of PRLX 93936.&#xD;
&#xD;
        -  To evaluate response to treatment, time to response (TTR) and duration of response.&#xD;
&#xD;
        -  To evaluate time to progression (TTP).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">March 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Maximum Tolerated Dose</measure>
    <time_frame>Cycle 1 (28 days from first dose)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response to treatment</measure>
    <time_frame>Each cycle (assessed every 28 days starting from first dose, for up to 8 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response</measure>
    <time_frame>From date of first dose to date of response, assessed up to 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>From date of response to first documented progression or death, or date last known progression-free and alive at study discontinuation, assessed up to 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression</measure>
    <time_frame>From date of first dose to first documented progression, assessed up to 8 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>PRLX 93936</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRLX 93936</intervention_name>
    <description>PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle, multiple cycles may be administered</description>
    <arm_group_label>PRLX 93936</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must have a diagnosis of multiple myeloma and have relapsed or&#xD;
             relapsed/refractory disease.&#xD;
&#xD;
          -  Patient must have received ≥ 2 prior anti-myeloma regimens including a proteasome&#xD;
             inhibitor and/or immunomodulatory agent.&#xD;
&#xD;
          -  Patient currently requires systemic therapy.&#xD;
&#xD;
          -  Patient has measurable disease.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Karnofsky performance status ≥ 60%&#xD;
&#xD;
          -  ECOG performance 0, 1 or 2&#xD;
&#xD;
          -  Life expectancy of at least three months&#xD;
&#xD;
          -  Able to take acetaminophen&#xD;
&#xD;
          -  Not pregnant&#xD;
&#xD;
          -  Patient must have recovered from toxicities incurred as a result of any previous&#xD;
             anti-myeloma therapy or recovered to baseline.&#xD;
&#xD;
          -  Patients who received an autologous stem cell transplant must be ≥ 3 months&#xD;
             post-transplant and all associated toxicities must have resolved to ≤ CTCAE Grade 1.&#xD;
&#xD;
          -  QT intervals of QTc ≤ 500 msec&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  POEMS syndrome&#xD;
&#xD;
          -  Plasma cell leukemia&#xD;
&#xD;
          -  Primary amyloidosis&#xD;
&#xD;
          -  Patient has smoldering multiple myeloma or monoclonal gammopathy of unknown&#xD;
             significance (MGUS).&#xD;
&#xD;
          -  Evidence of spinal cord compression or CNS complication unless controlled by&#xD;
             appropriate therapy.&#xD;
&#xD;
          -  Patient received chemotherapy or other anti-cancer therapy that may be active against&#xD;
             multiple myeloma within 3 weeks prior to the first dose of PRLX 93936.&#xD;
&#xD;
          -  Patient received nitrosureas within 6 weeks prior to the first dose.&#xD;
&#xD;
          -  Patient received corticosteroids within 2 weeks prior to the first dose.&#xD;
&#xD;
          -  Patient received plasmapheresis within 4 weeks prior to the first dose.&#xD;
&#xD;
          -  Patient had major surgery within 4 weeks prior to the first dose.&#xD;
&#xD;
          -  Patient had an allogeneic stem cell transplant within 6 months before first dose of&#xD;
             PRLX 93936 or has evidence of graft versus host disease.&#xD;
&#xD;
          -  Patient is taking any therapy concomitantly that may be active against multiple&#xD;
             myeloma.&#xD;
&#xD;
          -  Patient is currently receiving medication(s) that are principally metabolized via the&#xD;
             cytochrome P450 3A4 enzyme pathway.&#xD;
&#xD;
          -  Use of any investigational agents within 28 days or 5 half-lives (whichever is&#xD;
             shorter) of study treatment.&#xD;
&#xD;
          -  Patient has peripheral neuropathy of Grade 3 or greater intensity, or painful Grade 2,&#xD;
             as defined by the NCI CTC.&#xD;
&#xD;
          -  Patient had a myocardial infarction within 6 months of enrollment or has NYHA Class&#xD;
             III or IV heart failure uncontrolled angina, severe uncontrolled ventricular&#xD;
             arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction&#xD;
             system abnormalities.&#xD;
&#xD;
          -  Abnormal LVEF (&lt; LLN for the institution for a patient of that age) on echocardiogram&#xD;
&#xD;
          -  Patient has poorly controlled hypertension, diabetes mellitus, or other serious&#xD;
             medical or psychiatric illness that could potentially interfere with the completion of&#xD;
             treatment according to protocol.&#xD;
&#xD;
          -  Patient had a malignancy other than multiple myeloma within 3 years before enrollment,&#xD;
             with the exception of adequately treated basal cell or squamous cell skin cancer, in&#xD;
             situ cervical cancer, in situ breast cancer, or in situ prostate cancer.&#xD;
&#xD;
          -  Patient's clinical laboratory values meet any of the following criteria within the 7&#xD;
             days prior to Study Day 1:&#xD;
&#xD;
               -  Bilirubin &gt; 1.5 times ULN&#xD;
&#xD;
               -  AST (SGOT), ALT (SGPT) and Alkaline phosphatase &gt; 2.5 times ULN&#xD;
&#xD;
               -  Uncontrolled hypercalcemia (defined as serum calcium &gt; 14 mg/dL)&#xD;
&#xD;
               -  Serum creatinine &gt; 2.0 mg/dL or creatinine clearance of &lt; 30 mL/min&#xD;
&#xD;
               -  ANC &lt; 1000 cells/mm3 or &lt; 750 cells/mm3 due to &gt;50% marrow involvement&#xD;
&#xD;
               -  Platelet count &lt; 50,000 cells/mm3&#xD;
&#xD;
               -  Hemoglobin &lt; 8.0 g/dL&#xD;
&#xD;
          -  Patient is known to be human immunodeficiency virus (HIV)-positive.&#xD;
&#xD;
          -  Patient is known to be hepatitis B surface antigen-positive or has known active&#xD;
             hepatitis C infection.&#xD;
&#xD;
          -  Patient has an active systemic infection requiring treatment or within 14 days before&#xD;
             first dose of PRLX 93936.&#xD;
&#xD;
          -  Pregnant or nursing women&#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>Paul Richardson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Destefanis</last_name>
      <phone>617-632-6752</phone>
      <email>amyl_destefanis@dfci.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Robert Schlossman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Riff</last_name>
      <phone>919-843-7046</phone>
      <email>barbara_riff@med.unc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Katherine McKernan</last_name>
      <phone>919-966-4432</phone>
      <email>katherine_mckernan@med.unc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Peter Voorhees, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberly Oates</last_name>
      <phone>919-668-6524</phone>
      <email>kimberly.bartlett@duke.edu</email>
    </contact>
    <investigator>
      <last_name>Cristina Gasparetto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sue O'Gara</last_name>
      <phone>513-604-3982</phone>
      <email>sue.ogara@uc.edu</email>
    </contact>
    <investigator>
      <last_name>John Morris, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cindy Farley</last_name>
      <phone>615-329-7237</phone>
      <email>cindy.farley@scresearch.net</email>
    </contact>
    <investigator>
      <last_name>Jesus G. Berdeja, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>May 31, 2013</last_update_submitted>
  <last_update_submitted_qc>May 31, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myeloma</keyword>
  <keyword>PRLX93936</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</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/NCT01695590
org study id: PRLX93936-0002
nct id: NCT01695590
lead sponsor: 
has dmc: No
To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for
      patients with relapsed or relapsed/refractory multiple myeloma.
-  To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of
           PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks
           followed by a 9 day rest period, as treatment for patients with relapsed or
           relapsed/refractory multiple myeloma.

        -  To establish the dose of PRLX 93936 recommended for future studies.

        -  To characterize potential toxicities of PRLX 93936.

        -  To assess the pharmacokinetic profile of PRLX 93936.

        -  To evaluate response to treatment, time to response (TTR) and duration of response.

        -  To evaluate time to progression (TTP).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose
time frame: Cycle 1 (28 days from first dose)
measure: Response to treatment
time frame: Each cycle (assessed every 28 days starting from first dose, for up to 8 months)
measure: Time to response
time frame: From date of first dose to date of response, assessed up to 8 months
measure: Duration of response
time frame: From date of response to first documented progression or death, or date last known progression-free and alive at study discontinuation, assessed up to 8 months
measure: Time to progression
time frame: From date of first dose to first documented progression, assessed up to 8 months
arm group label: PRLX 93936
arm group type: Experimental
description: PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle
intervention type: Drug
intervention name: PRLX 93936
description: PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle, multiple cycles may be administered
arm group label: PRLX 93936
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Richardson, MD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell