<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/NCT02970643</url>
  </required_header>
  <id_info>
    <org_study_id>C2016034</org_study_id>
    <nct_id>NCT02970643</nct_id>
  </id_info>
  <brief_title>Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN</brief_title>
  <official_title>Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hee Jun Kim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HK inno.N Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chung-Ang University Hosptial, Chung-Ang University College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Palonosetron and Olanzapine without&#xD;
      dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was designed to evaluate efficacy and safety of olanzapine compared with&#xD;
      5-hydroxytryptamine3 receptor antagonist for prevention of moderate risk chemotherapy induced&#xD;
      nausea and vomiting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea</measure>
    <time_frame>the overall assessment period (0 to 72 hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life was evaluated according to MDASI-K</measure>
    <time_frame>the overall assessment period (0 to 72 hours)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Chemotherapy-induced Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Olanzapine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olanzapine</intervention_name>
    <description>Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO</description>
    <arm_group_label>Olanzapine group</arm_group_label>
    <other_name>Zyprexa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palonosetron</intervention_name>
    <description>Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV</description>
    <arm_group_label>Olanzapine group</arm_group_label>
    <other_name>Aloxi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2&#xD;
&#xD;
          -  no severe cognitive compromise&#xD;
&#xD;
          -  Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st&#xD;
             cycle&#xD;
&#xD;
          -  Confirmed histology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  European Cooperative Oncology Group (ECOG) performance status of 3 and 4&#xD;
&#xD;
          -  Nausea or vomiting in the 24 hours before enrollment&#xD;
&#xD;
          -  History of Nausea or vomiting Grade 3 before previous chemotherapy&#xD;
&#xD;
          -  Known history of central nervous system disease (e.g., brain metastases or a seizure&#xD;
             disorder)&#xD;
&#xD;
          -  Bowel obstruction&#xD;
&#xD;
          -  Serum creatinine level of 2.0 mg per deciliter (177 μmol per liter) or more&#xD;
&#xD;
          -  Aspartate or alanine aminotransferase level that was more than 3 times the upper limit&#xD;
             of the normal range&#xD;
&#xD;
          -  Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine,&#xD;
             a phenothiazine, or a butyrophenone within 30 days before enrollment&#xD;
&#xD;
          -  Treatment with another antiemetic agent before 48 hours before enrollment&#xD;
&#xD;
          -  Uncontrolled severe infection or uncontrolled severe comorbidity&#xD;
&#xD;
          -  Concurrent abdominal radiotherapy&#xD;
&#xD;
          -  Known hypersensitivity to olanzapine, palonosetron&#xD;
&#xD;
          -  Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial&#xD;
             infarction within the previous 6 month&#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>Heejun Kim, MD.PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <reference>
    <citation>Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.</citation>
    <PMID>27410922</PMID>
  </reference>
  <reference>
    <citation>Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.</citation>
    <PMID>19775450</PMID>
  </reference>
  <reference>
    <citation>Naeim A, Dy SM, Lorenz KA, Sanati H, Walling A, Asch SM. Evidence-based recommendations for cancer nausea and vomiting. J Clin Oncol. 2008 Aug 10;26(23):3903-10. doi: 10.1200/JCO.2007.15.9533.</citation>
    <PMID>18688059</PMID>
  </reference>
  <reference>
    <citation>Lohr L. Chemotherapy-induced nausea and vomiting. Cancer J. 2008 Mar-Apr;14(2):85-93. doi: 10.1097/PPO.0b013e31816a0f07.</citation>
    <PMID>18391612</PMID>
  </reference>
  <reference>
    <citation>American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. doi: 10.1200/JCO.2006.06.9591. Epub 2006 May 22. Erratum In: J Clin Oncol. 2006 Nov 20;24(33):5341-2.</citation>
    <PMID>16717289</PMID>
  </reference>
  <reference>
    <citation>Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.</citation>
    <PMID>22024310</PMID>
  </reference>
  <reference>
    <citation>Vardy J, Chiew KS, Galica J, Pond GR, Tannock IF. Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy. Br J Cancer. 2006 Apr 10;94(7):1011-5. doi: 10.1038/sj.bjc.6603048.</citation>
    <PMID>16552437</PMID>
  </reference>
  <reference>
    <citation>Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v.</citation>
    <PMID>11013380</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Chung-Ang University Hosptial, Chung-Ang University College of Medicine</investigator_affiliation>
    <investigator_full_name>Hee Jun Kim</investigator_full_name>
    <investigator_title>Associate Professor,Division of Hemato-oncology</investigator_title>
  </responsible_party>
  <keyword>Olanzapine</keyword>
  <keyword>Chemotherapy-Induced Nausea and Vomiting</keyword>
  <keyword>Moderate risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olanzapine</mesh_term>
    <mesh_term>Palonosetron</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/NCT02970643
org study id: C2016034
nct id: NCT02970643
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether Palonosetron and Olanzapine without
      dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.
This study was designed to evaluate efficacy and safety of olanzapine compared with
      5-hydroxytryptamine3 receptor antagonist for prevention of moderate risk chemotherapy induced
      nausea and vomiting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea
time frame: the overall assessment period (0 to 72 hours)
measure: Quality of life was evaluated according to MDASI-K
time frame: the overall assessment period (0 to 72 hours)
arm group label: Olanzapine group
arm group type: Experimental
description: Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group
intervention type: Drug
intervention name: Olanzapine
description: Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO
arm group label: Olanzapine group
other name: Zyprexa
intervention type: Drug
intervention name: Palonosetron
description: Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV
arm group label: Olanzapine group
other name: Aloxi
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heejun Kim, MD.PhD
role: Study Chair
affiliation: Associate Professor
citation: Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.
PMID: 27410922
citation: Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.
PMID: 19775450
citation: Naeim A, Dy SM, Lorenz KA, Sanati H, Walling A, Asch SM. Evidence-based recommendations for cancer nausea and vomiting. J Clin Oncol. 2008 Aug 10;26(23):3903-10. doi: 10.1200/JCO.2007.15.9533.
PMID: 18688059
citation: Lohr L. Chemotherapy-induced nausea and vomiting. Cancer J. 2008 Mar-Apr;14(2):85-93. doi: 10.1097/PPO.0b013e31816a0f07.
PMID: 18391612
citation: American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. doi: 10.1200/JCO.2006.06.9591. Epub 2006 May 22. Erratum In: J Clin Oncol. 2006 Nov 20;24(33):5341-2.
PMID: 16717289
citation: Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.
PMID: 22024310
citation: Vardy J, Chiew KS, Galica J, Pond GR, Tannock IF. Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy. Br J Cancer. 2006 Apr 10;94(7):1011-5. doi: 10.1038/sj.bjc.6603048.
PMID: 16552437
citation: Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v.
PMID: 11013380
responsible party type: Sponsor-Investigator
investigator affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
investigator full name: Hee Jun Kim
investigator title: Associate Professor,Division of Hemato-oncology
mesh term: Nausea
mesh term: Vomiting
mesh term: Olanzapine
mesh term: Palonosetron
sharing ipd: No