<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/NCT04503668</url>
  </required_header>
  <id_info>
    <org_study_id>UMCC 2019.173</org_study_id>
    <secondary_id>HUM00175458</secondary_id>
    <nct_id>NCT04503668</nct_id>
  </id_info>
  <brief_title>Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients</brief_title>
  <official_title>Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the efficacy of olanzapine as compared to&#xD;
      neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea&#xD;
      and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient&#xD;
      chemotherapy (carboplatin and paclitaxel) every 3 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 28, 2020</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of complete response in the overall time period (0 - 120 hours post-chemotherapy)</measure>
    <time_frame>At day 6</time_frame>
    <description>Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of complete response in the acute time period (0 - 24 hours post-chemotherapy)</measure>
    <time_frame>At day 2</time_frame>
    <description>Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complete response in the delayed time period (24 - 120 hours post-chemotherapy)</measure>
    <time_frame>At day 6</time_frame>
    <description>Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of no nausea in the acute time period (0 - 24 hours post-chemotherapy)</measure>
    <time_frame>At day 2</time_frame>
    <description>Patients will record daily levels of nausea after chemotherapy using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of no nausea in the delayed time period (24 - 120 hours post-chemotherapy)</measure>
    <time_frame>At day 6</time_frame>
    <description>Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of no nausea in the overall time period (0 - 120 hours post-chemotherapy)</measure>
    <time_frame>At day 6</time_frame>
    <description>Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean somnolence score</measure>
    <time_frame>At day 6</time_frame>
    <description>Patients will record daily levels of undesired sedation using a Likert scale ranging from 0 to 10 (0 indicating no undesired sedation; 10 indicating maximum level of undesired sedation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean increased-appetite score</measure>
    <time_frame>At day 6</time_frame>
    <description>Patients will record daily levels of undesired increase in appetite using a Likert scale ranging from 0 to 10 (0 indicating no undesired increase in appetite; 10 indicating maximum level of undesired increase in appetite).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Gynecologic Cancer</condition>
  <arm_group>
    <arm_group_label>Nk1-RA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Olanzapine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy</description>
    <arm_group_label>Nk1-RA</arm_group_label>
    <arm_group_label>Olanzapine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>20 mg IV on day 1 pre-chemotherapy</description>
    <arm_group_label>Nk1-RA</arm_group_label>
    <arm_group_label>Olanzapine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neurokinin-1 Receptor Antagonist (NK1-RA)</intervention_name>
    <description>150 mg IV on day 1 pre-chemotherapy</description>
    <arm_group_label>Nk1-RA</arm_group_label>
    <other_name>Fosaprepitant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olanzapine</intervention_name>
    <description>5 mg by mouth on days 1-4 of chemotherapy (taken at night)</description>
    <arm_group_label>Olanzapine</arm_group_label>
    <other_name>Zyprexa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Compazine</intervention_name>
    <description>5-10 mg by mouth, available as needed, every 6 hours, days 1-5</description>
    <arm_group_label>Nk1-RA</arm_group_label>
    <arm_group_label>Olanzapine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of gynecologic malignancy&#xD;
&#xD;
          -  No chemotherapy in the last 12 months&#xD;
&#xD;
          -  Scheduled to receive Carboplatin (AUC&gt;=4) and Paclitaxel every three weeks&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  Laboratory values within protocol-defined parameters&#xD;
&#xD;
          -  No vomiting in the 24 hours prior to initiating chemotherapy&#xD;
&#xD;
          -  If childbearing potential exists, negative pregnancy test within 7 days prior to&#xD;
             registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cognitive compromise&#xD;
&#xD;
          -  History of CNS disease (e.g. brain metastases, seizure disorder, dementia)&#xD;
&#xD;
          -  Current or recent (within 30 days) treatment with another antipsychotic agent&#xD;
             (antidepressant medications are OK)&#xD;
&#xD;
          -  Concurrent radiotherapy treatment&#xD;
&#xD;
          -  Known hypersensitivity to olanzapine&#xD;
&#xD;
          -  Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial&#xD;
             infarction within the last six months&#xD;
&#xD;
          -  History of diabetes mellitus on medication (insulin or oral glycemic agent)&#xD;
&#xD;
          -  Alcohol abuse / chronic alcoholism&#xD;
&#xD;
          -  History of closed angle glaucoma&#xD;
&#xD;
          -  Current enrollment in other clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shitanshu Uppal, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Rogel Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Rogel Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caitlin McCarthy</last_name>
      <phone>734-615-5118</phone>
      <email>caitlimc@med.umich.edu</email>
    </contact>
    <contact_backup>
      <last_name>Aimee Rolston, MD, MS</last_name>
      <email>aimeerol@med.umich.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Shitanshu Uppal, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aimee Rolston, MD, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</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>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Ondansetron</mesh_term>
    <mesh_term>Olanzapine</mesh_term>
    <mesh_term>Fosaprepitant</mesh_term>
    <mesh_term>Prochlorperazine</mesh_term>
    <mesh_term>Neurokinin-1 Receptor Antagonists</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04503668
org study id: UMCC 2019.173
secondary id: HUM00175458
nct id: NCT04503668
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The objective of this study is to investigate the efficacy of olanzapine as compared to
      neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea
      and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient
      chemotherapy (carboplatin and paclitaxel) every 3 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of complete response in the overall time period (0 - 120 hours post-chemotherapy)
time frame: At day 6
description: Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.
measure: Rate of complete response in the acute time period (0 - 24 hours post-chemotherapy)
time frame: At day 2
description: Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.
measure: Rate of complete response in the delayed time period (24 - 120 hours post-chemotherapy)
time frame: At day 6
description: Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.
measure: Rate of no nausea in the acute time period (0 - 24 hours post-chemotherapy)
time frame: At day 2
description: Patients will record daily levels of nausea after chemotherapy using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).
measure: Rate of no nausea in the delayed time period (24 - 120 hours post-chemotherapy)
time frame: At day 6
description: Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).
measure: Rate of no nausea in the overall time period (0 - 120 hours post-chemotherapy)
time frame: At day 6
description: Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).
measure: Mean somnolence score
time frame: At day 6
description: Patients will record daily levels of undesired sedation using a Likert scale ranging from 0 to 10 (0 indicating no undesired sedation; 10 indicating maximum level of undesired sedation).
measure: Mean increased-appetite score
time frame: At day 6
description: Patients will record daily levels of undesired increase in appetite using a Likert scale ranging from 0 to 10 (0 indicating no undesired increase in appetite; 10 indicating maximum level of undesired increase in appetite).
arm group label: Nk1-RA
arm group type: Active Comparator
description: Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
arm group label: Olanzapine
arm group type: Experimental
description: Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
intervention type: Drug
intervention name: Ondansetron
description: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy
arm group label: Nk1-RA
arm group label: Olanzapine
intervention type: Drug
intervention name: Dexamethasone
description: 20 mg IV on day 1 pre-chemotherapy
arm group label: Nk1-RA
arm group label: Olanzapine
intervention type: Drug
intervention name: Neurokinin-1 Receptor Antagonist (NK1-RA)
description: 150 mg IV on day 1 pre-chemotherapy
arm group label: Nk1-RA
other name: Fosaprepitant
intervention type: Drug
intervention name: Olanzapine
description: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)
arm group label: Olanzapine
other name: Zyprexa
intervention type: Drug
intervention name: Compazine
description: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
arm group label: Nk1-RA
arm group label: Olanzapine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Shitanshu Uppal, MBBS
role: Principal Investigator
affiliation: University of Michigan Rogel Cancer Center
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Vomiting
mesh term: Dexamethasone
mesh term: Ondansetron
mesh term: Olanzapine
mesh term: Fosaprepitant
mesh term: Prochlorperazine
mesh term: Neurokinin-1 Receptor Antagonists
sharing ipd: No