<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/NCT01677780</url>
  </required_header>
  <id_info>
    <org_study_id>NP28366</org_study_id>
    <secondary_id>2012-001303-20</secondary_id>
    <nct_id>NCT01677780</nct_id>
  </id_info>
  <brief_title>An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies</brief_title>
  <official_title>A Multi-Center, Open-Label, Extension Study of RO5045337 (MDM2 Antagonist) Administered Orally in Patients Treated With RO5045337 on Previous Roche-Sponsored Phase 1 Cancer Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This open-label, extension study is designed to provide continuing treatment with RO5045337&#xD;
      to participants who have completed parent studies NO21279 (NCT00623870), NO21280&#xD;
      (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).&#xD;
      Participants are eligible to participate in this study if they have completed required Phase&#xD;
      1 study assessments for primary objectives of respective parent protocol and are having&#xD;
      evidence of clinical benefit (as defined by the parent protocol). Participants will continue&#xD;
      the most similar dose and formulation available (which does not exceed the maximum tolerated&#xD;
      dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and&#xD;
      the same schedule of RO5045337 treatment that they were receiving at the time of&#xD;
      transitioning from the parent clinical study protocol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2012</start_date>
  <completion_date type="Actual">June 26, 2017</completion_date>
  <primary_completion_date type="Actual">June 26, 2017</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>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Approximately 24 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute</condition>
  <arm_group>
    <arm_group_label>RO5045337</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will continue the most similar dose and formulation available (which does not exceed the MTD or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from their respective parent clinical study protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO5045337</intervention_name>
    <description>Participants will receive RO5045337 orally in doses ranging from 20 milligram per square meter (mg/m^2) to 1800 mg/m^2 daily, and up to 1500 mg dose twice daily on a variety of schedules including daily for up to 20 days and weekly dosing for 3 weeks in 28 day cycles until disease progression or unacceptable toxicity with maximum treatment duration of 24 months.</description>
    <arm_group_label>RO5045337</arm_group_label>
    <other_name>MDM2 ANTAGONIST</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must meet the inclusion criteria outlined in the respective parent&#xD;
             protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033),&#xD;
             NP28021 (NCT01605526) or NP28023 (NCT01635296)&#xD;
&#xD;
          -  Participants must have completed one of the following clinical study protocols and&#xD;
             have been determined to have clinical benefit on treatment at the conclusion of&#xD;
             required study analyses as defined in the respective parent protocols: NO21279&#xD;
             (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or&#xD;
             NP28023 (NCT01635296)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must meet the exclusion criteria outlined in the respective parent&#xD;
             protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033),&#xD;
             NP28021 (NCT01605526) or NP28023 (NCT01635296)&#xD;
&#xD;
          -  Participants who developed disease progression/ requiring other anti-tumor therapy&#xD;
             while in the parent protocol&#xD;
&#xD;
          -  Participants who have stopped study drug dosing for greater than 56 days&#xD;
&#xD;
          -  Participants continuing to require dose modifications&#xD;
&#xD;
          -  Participants with worsening adverse events&#xD;
&#xD;
          -  Participants with unrelated adverse events, medical illnesses, or changes in&#xD;
             performance status that, per investigator discretion, put them at high risk for&#xD;
             continuing participation in the clinical study&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sarcoma Oncology Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.D Anderson Cancer Center; Oncology</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Therapy &amp; Research Ctr; Dept Institute for Drug Development</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital, Medical Oncology &amp; Haematology</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud; Departement Oncologie Medicale</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Italy</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>July 5, 2017</last_update_submitted>
  <last_update_submitted_qc>July 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2017</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>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</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/NCT01677780
org study id: NP28366
secondary id: 2012-001303-20
nct id: NCT01677780
lead sponsor: 
This open-label, extension study is designed to provide continuing treatment with RO5045337
      to participants who have completed parent studies NO21279 (NCT00623870), NO21280
      (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).
      Participants are eligible to participate in this study if they have completed required Phase
      1 study assessments for primary objectives of respective parent protocol and are having
      evidence of clinical benefit (as defined by the parent protocol). Participants will continue
      the most similar dose and formulation available (which does not exceed the maximum tolerated
      dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and
      the same schedule of RO5045337 treatment that they were receiving at the time of
      transitioning from the parent clinical study protocol.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Approximately 24 months
arm group label: RO5045337
arm group type: Experimental
description: Participants will continue the most similar dose and formulation available (which does not exceed the MTD or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from their respective parent clinical study protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).
intervention type: Drug
intervention name: RO5045337
description: Participants will receive RO5045337 orally in doses ranging from 20 milligram per square meter (mg/m^2) to 1800 mg/m^2 daily, and up to 1500 mg dose twice daily on a variety of schedules including daily for up to 20 days and weekly dosing for 3 weeks in 28 day cycles until disease progression or unacceptable toxicity with maximum treatment duration of 24 months.
arm group label: RO5045337
other name: MDM2 ANTAGONIST
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: France
country: United States
country: Italy
country: United Kingdom
responsible party type: Sponsor
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Leukemia, Myeloid, Acute