<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/NCT01662687</url>
  </required_header>
  <id_info>
    <org_study_id>LG-SCSCL002</org_study_id>
    <nct_id>NCT01662687</nct_id>
  </id_info>
  <brief_title>Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in CINV (Chemotherapy-induced Nausea and Vomiting) Associated With the Administration of MEC (Moderately Emetogenic Chemotherapy)</brief_title>
  <official_title>Randomized Study of the Efficacy and Safety of Transdermal Granisetron Compared With Intravenous and Oral Agent in the Control of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LG Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LG Life Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to&#xD;
      demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared&#xD;
      with the intravenous and oral Granisetron in the prevention of CINV associated with&#xD;
      moderately emetogenic Chemotherapy.&#xD;
&#xD;
      Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for 1-4&#xD;
      days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy. Eligible&#xD;
      patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2&#xD;
      days prior to ME chemotherapy).&#xD;
&#xD;
        -  Sancuso patch&#xD;
&#xD;
        -  Kytril inj.+Kytril tab.&#xD;
&#xD;
      The patch will be applied 2days (48-24h) prior to first daily dose of the moderately&#xD;
      emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed&#xD;
      daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be&#xD;
      collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up until&#xD;
      14 days after the final dose of IP. Serious adverse events will be followed-up until they are&#xD;
      resolved, stable or until the patient is lost to follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">November 2012</completion_date>
  <primary_completion_date type="Anticipated">October 2012</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients achieving Complete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen</measure>
    <time_frame>from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients achieving Complete Response (CR)</measure>
    <time_frame>overall (Day 1~4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients achieving Complete Control (CC) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen</measure>
    <time_frame>from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients achieving Complete Control (CC)</measure>
    <time_frame>overall (Day 1~4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of nausea</measure>
    <time_frame>overall (Day 1~4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of vomiting</measure>
    <time_frame>overall (Day 1~4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of nausea from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen</measure>
    <time_frame>from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen</measure>
    <time_frame>from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction with anti-emetic therapy (Changes from Baseline to Day 5)</measure>
    <time_frame>from baseline to Day 5</time_frame>
    <description>The patient's response to anti-emetic therapy was assessed and recorded by patients at Visit 3 (Baseline) and Visit 7 (Day 5). The patient was asked to evaluate his/her satisfaction with the control of nausea and vomiting by marking the FLI-E (Functional Living Index - Emesis) with vertical lines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients achieving Complete Response (CR)</measure>
    <time_frame>per day (Day 1, 2, 3, 4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients achieving Complete Control (CC)</measure>
    <time_frame>per day (Day 1, 2, 3, 4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of nausea</measure>
    <time_frame>per day (Day 1, 2, 3, 4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of vomiting</measure>
    <time_frame>per day (Day 1, 2, 3, 4)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">276</enrollment>
  <condition>Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)</condition>
  <arm_group>
    <arm_group_label>Sancuso patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Kytril</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sancuso patch</intervention_name>
    <description>Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days.&#xD;
Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24 hours) prior to start of chemotherapy.</description>
    <arm_group_label>Sancuso patch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kytril inj.+Kytril tab.</intervention_name>
    <description>Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days.&#xD;
Active Comparator arm:&#xD;
Kytril inj. 3mg: administered by intravenous infusion at least 5 minutes, just before the first chemotherapy (Day 1).&#xD;
Kytril tab. 1mg: administered twice a day by orally at Day 2~4.</description>
    <arm_group_label>Kytril</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female aged over 20 yrs&#xD;
&#xD;
          2. Histologically and/or cytologically proven cancer patients&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group performance status 0, 1, 2&#xD;
&#xD;
          4. A cycle of moderately emetogenic chemotherapy(NCCN Guidelines)&#xD;
&#xD;
          5. Life expectancy of ≥ 3 months&#xD;
&#xD;
          6. Normal liver function and renal function(total bilirubin ≤ 1.5 ULN, AST/ALT ≤ 2.5 ULN,&#xD;
             in case of liver metastases AST/ALT ≤ 5 ULN, serum creatinine ≤ 1.5 ULN) patients&#xD;
&#xD;
          7. Patients who signed the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A. Previous History&#xD;
&#xD;
          1. Hypersensitivity to adhesive plasters&#xD;
&#xD;
          2. Contraindications to 5-HT3 receptor antagonists&#xD;
&#xD;
          3. Any other relevant medical history (at the discretion of the investigator)&#xD;
&#xD;
        B. Concomitant Medical Condition&#xD;
&#xD;
          1. Current alcohol, drug or medication abuse&#xD;
&#xD;
          2. Currently pregnant or breast feeding women, including planning pregnancy&#xD;
&#xD;
          3. Clinically relevant abnormal laboratory values (at the discretion of the investigator)&#xD;
&#xD;
          4. Clinically relevant heart, hepatic, renal, infectious, neurological or psychiatric&#xD;
             disorders, or any other major systemic illness (at the discretion of the investigator)&#xD;
&#xD;
          5. Any cause for nausea and vomiting other than CINV&#xD;
&#xD;
          6. Any episode of retching, vomiting or uncontrolled nausea in the 72 h period prior to&#xD;
             the chemotherapy administration&#xD;
&#xD;
          7. Clinically relevant abnormal ECG parameters (at the discretion of the investigator)&#xD;
&#xD;
        C. Concomitant Therapy/Medication&#xD;
&#xD;
          1. Concomitant radiotherapy of total body, brain or upper abdomen within one week prior&#xD;
             to the study entry or planned during the study&#xD;
&#xD;
          2. Intake of medication to control the symptoms of a brain tumor, brain metastasis or&#xD;
             seizure disorder or neuropathy (unless peripheral neuropathy at the discretion of the&#xD;
             investigator)&#xD;
&#xD;
          3. Patients using selective serotonin reuptake inhibitor (SSRI) antidepressants (unless a&#xD;
             stable dose for the duration of the study)&#xD;
&#xD;
          4. Receipt of a narcotic analgesics (acceptable at the discretion of the investigator)&#xD;
&#xD;
          5. Receipt of any other clinical trial drug &lt; 30 days before the study or during the&#xD;
             study&#xD;
&#xD;
          6. Scheduled to receive a neurokinin NK1 receptor antagonist, dopamine receptor&#xD;
             antagonist or another 5-HT3 receptor antagonist at 72 h prior to the administration of&#xD;
             the chemotherapy or scheduled to do those medication during chemotherapy duration&#xD;
&#xD;
          7. Drugs known to increase the QTc interval (unless a stable dose for the duration of the&#xD;
             study at the discretion of the investigator)&#xD;
&#xD;
        D. Other&#xD;
&#xD;
          1. Patients unlikely to comply with the study protocol (at the discretion of the&#xD;
             investigator), e.g. uncooperative attitude, inability to return for follow-up visits&#xD;
             and unlikelihood of completing the study&#xD;
&#xD;
          2. The patch adhesion level was not more than 50% on the day of chemotherapy or the patch&#xD;
             was not attached within two days before the chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Seok Ahn, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tae Won Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dong Bok Shin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University Gil Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yun-Ae Eom, BS</last_name>
    <phone>82-2-6924-3157</phone>
    <email>yaeom@lgls.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Seok Ahn, MD, PhD</last_name>
      <phone>82-2-3410-3453</phone>
      <email>ajis@skku.edu</email>
    </contact>
    <investigator>
      <last_name>Jin Seok Ahn, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 15, 2012</last_update_submitted>
  <last_update_submitted_qc>August 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</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>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>Granisetron</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/NCT01662687
org study id: LG-SCSCL002
nct id: NCT01662687
lead sponsor: 
has dmc: No
Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to
      demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared
      with the intravenous and oral Granisetron in the prevention of CINV associated with
      moderately emetogenic Chemotherapy.

      Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for 1-4
      days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy. Eligible
      patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2
      days prior to ME chemotherapy).

        -  Sancuso patch

        -  Kytril inj.+Kytril tab.

      The patch will be applied 2days (48-24h) prior to first daily dose of the moderately
      emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed
      daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be
      collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up until
      14 days after the final dose of IP. Serious adverse events will be followed-up until they are
      resolved, stable or until the patient is lost to follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The percentage of patients achieving Complete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
measure: The percentage of patients achieving Complete Response (CR)
time frame: overall (Day 1~4)
measure: The percentage of patients achieving Complete Control (CC) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
measure: The percentage of patients achieving Complete Control (CC)
time frame: overall (Day 1~4)
measure: severity of nausea
time frame: overall (Day 1~4)
measure: severity of vomiting
time frame: overall (Day 1~4)
measure: Frequency of nausea from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
measure: Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
measure: Patient's satisfaction with anti-emetic therapy (Changes from Baseline to Day 5)
time frame: from baseline to Day 5
description: The patient's response to anti-emetic therapy was assessed and recorded by patients at Visit 3 (Baseline) and Visit 7 (Day 5). The patient was asked to evaluate his/her satisfaction with the control of nausea and vomiting by marking the FLI-E (Functional Living Index - Emesis) with vertical lines.
measure: The percentage of patients achieving Complete Response (CR)
time frame: per day (Day 1, 2, 3, 4)
measure: The percentage of patients achieving Complete Control (CC)
time frame: per day (Day 1, 2, 3, 4)
measure: severity of nausea
time frame: per day (Day 1, 2, 3, 4)
measure: severity of vomiting
time frame: per day (Day 1, 2, 3, 4)
arm group label: Sancuso patch
arm group type: Experimental
arm group label: Kytril
arm group type: Active Comparator
intervention type: Drug
intervention name: Sancuso patch
description: Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days.
Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24 hours) prior to start of chemotherapy.
arm group label: Sancuso patch
intervention type: Drug
intervention name: Kytril inj.+Kytril tab.
description: Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days.
Active Comparator arm:
Kytril inj. 3mg: administered by intravenous infusion at least 5 minutes, just before the first chemotherapy (Day 1).
Kytril tab. 1mg: administered twice a day by orally at Day 2~4.
arm group label: Kytril
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jin Seok Ahn, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Tae Won Kim, MD, PhD
role: Principal Investigator
affiliation: Asan Medical Center
last name: Dong Bok Shin, MD, PhD
role: Principal Investigator
affiliation: Gachon University Gil Medical Center
last name: Yun-Ae Eom, BS
phone: 82-2-6924-3157
email: yaeom@lgls.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
mesh term: Granisetron