xml: <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/NCT06038578</url>
    </required_header>
    <id_info>
      <org_study_id>950GCV01</org_study_id>
      <nct_id>NCT06038578</nct_id>
    </id_info>
    <brief_title>A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer</brief_title>
    <official_title>A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Toray Industries, Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Toray Industries, Inc</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will assess the efficacy, safety, optimal dose and ADA and NAbs development of&#xD;
        TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX)&#xD;
        as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal&#xD;
        junction (GEJ) adenocarcinoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will assess and compare the efficacy, safety, pharmacokinetics (PK), optimal dose&#xD;
        and anti-drug antibodies (ADA) and neutralizing antibodies (NAbs) development of TRK-950 at&#xD;
        two separate dose levels in combination with RAM + PTX as compared with RAM + PTX treatment&#xD;
        alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma. The&#xD;
        primary objective is progression free survival (PFS). Secondary objectives are overall&#xD;
        survival, objective response rate, best overall response, duration of response, disease&#xD;
        control rate, safety, pharmacokinetics, and immunogenicity of TRK-950 when used in&#xD;
        combination with RAM+PTX.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 27, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</primary_completion_date>
    <phase>Phase 2</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>Progression free Survival (PFS)</measure>
      <time_frame>Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months</time_frame>
      <description>Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on Independent Central Review.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>Time from the date of randomization to the date of death due to any cause, up to approximately 24 months</time_frame>
      <description>Overall survival is defined as the time from the date of randomization to the date of death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>From start of treatment to date of documented disease progression, up to approximately 24 months</time_frame>
      <description>Objective response rate (ORR) is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free Survival (PFS)</measure>
      <time_frame>Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months</time_frame>
      <description>Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on investigator assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>From start of treatment to date of documented disease progression, up to approximately 24 months</time_frame>
      <description>Objective response rate (ORR) is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best overall response (BOR)</measure>
      <time_frame>From start of treatment to date of documented disease progression, up to approximately 24 months</time_frame>
      <description>The best overall response is defined as the best overall response (BOR) recorded from the start of treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review based.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best overall response (BOR)</measure>
      <time_frame>From start of treatment to date of documented disease progression, up to approximately 24 months</time_frame>
      <description>The best overall response is defined as the best overall response (BOR) recorded from the start of treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>From start of treatment to date of documented disease progression, up to approximately 24 months</time_frame>
      <description>Disease control rate (DCR) is defined as the proportion of participants who achieve a best overall response of complete response (CR), partial response (PR) or stable disease (SD) for a minimum of 6 weeks using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review based.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>From start of treatment to date of documented disease progression, up to approximately 24 months</time_frame>
      <description>Disease control rate (DCR) is defined as the proportion of participants who achieve a best overall response of complete response (CR), partial response (PR) or stable disease (SD) for a minimum of 6 weeks using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DoR)</measure>
      <time_frame>Time from initial response (CR or PR) to date of documented disease progression or death due to any cause, whichever occurs first, up to approximately 24 months</time_frame>
      <description>Duration of response (DoR) is defined as the time from the initial response (CR or PR) until documented tumor progression or death from any cause based on Independent Central Review based.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DoR)</measure>
      <time_frame>Time from initial response (CR or PR) to date of documented disease progression or death due to any cause, whichever occurs first, up to approximately 24 months</time_frame>
      <description>Duration of response (DoR) is defined as the time from the initial response (CR or PR) until documented tumor progression or death from any cause based on investigator assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Treatment-emergent Adverse Events (TEAE)</measure>
      <time_frame>From time subjects are enrolled up to 45 days after last study dose</time_frame>
      <description>Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious Adverse Events (SAEs)</measure>
      <time_frame>From time subjects are enrolled up to 45 days after last study dose</time_frame>
      <description>Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events of Special Interest (AESI)</measure>
      <time_frame>From time subjects are enrolled up to 45 days after last study dose</time_frame>
      <description>Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Discontinuation due to AE</measure>
      <time_frame>From time subjects are enrolled up to 45 days after last study dose</time_frame>
      <description>Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Physical Examination Findings, Vital sign measurements, Standard clinical laboratory parameters, ECG parameters</measure>
      <time_frame>From time subjects signs informed consent form up to 45 days after last study dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of TRK-950</measure>
      <time_frame>Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of TRK-950</measure>
      <time_frame>Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter of Area Under the Curve (AUC) of TRK-950</measure>
      <time_frame>Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of Ramucirumab</measure>
      <time_frame>Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of Ramucirumab</measure>
      <time_frame>Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter of Area Under the Curve (AUC) of Ramucirumab</measure>
      <time_frame>Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of Paclitaxel</measure>
      <time_frame>Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of Paclitaxel</measure>
      <time_frame>Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter of Area Under the Curve (AUC) of Paclitaxel</measure>
      <time_frame>Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants who are Anti-drug antibody (ADA)-Positive and Neutralizing antibodies (NAbs)</measure>
      <time_frame>Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Patient Reported Quality of Life assessed by the Questionnaire - Core questionnaire EORTC QLQ-C30 scores</measure>
      <time_frame>From Cycle 1 on day 1 through study completion, up to approximately 24 months (each cycle is 28days)</time_frame>
      <description>The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life for cancer patients. It incorporates five functional scale (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Patient Reported Quality of Life assessed by Questionnaire - EuroQOL Five Dimensions questionnaire 3L (EQ-5D-3L) scores</measure>
      <time_frame>From Cycle 1 on day 1 through study completion, up to approximately 24 months (each cycle is 28days)</time_frame>
      <description>The EQ-5D questionnaire consists of the following five dimensions, each describing a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety/ Depression. The participants self-assess each dimension has three response levels of severity: no problems, some problems, extreme problems.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">146</enrollment>
    <condition>Gastric Adenocarcinoma</condition>
    <condition>Gastric Cancer</condition>
    <condition>Gastroesophageal Junction Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants who will be randomized to receive a 5 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants who will be randomized to receive a 10 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm C: Ramucirumab+Paclitaxel</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>TRK-950</intervention_name>
      <description>5 mg/kg or 10 mg/kg IV infusion over 60 minutes on Day 1, 8, 15 and 21 of each 28 day cycle</description>
      <arm_group_label>Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel</arm_group_label>
      <arm_group_label>Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ramucirumab</intervention_name>
      <description>8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle</description>
      <arm_group_label>Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel</arm_group_label>
      <arm_group_label>Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel</arm_group_label>
      <arm_group_label>Arm C: Ramucirumab+Paclitaxel</arm_group_label>
      <other_name>CYRAMZA®</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Paclitaxel</intervention_name>
      <description>80 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle</description>
      <arm_group_label>Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel</arm_group_label>
      <arm_group_label>Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel</arm_group_label>
      <arm_group_label>Arm C: Ramucirumab+Paclitaxel</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically or cytologically confirmed metastatic, or locally advanced and&#xD;
               unresectable gastric or GEJ adenocarcinoma.&#xD;
  &#xD;
            -  The patient is eligible to receive Ramucirumab + Paclitaxel as second-line therapy.&#xD;
  &#xD;
            -  Documented objective radiographic or clinical disease progression (e.g., any new or&#xD;
               worsening malignant effusion documented by ultrasound examination) which may be&#xD;
               confirmed by pathologic criteria (histology and/or cytology) if appropriate, during&#xD;
               any first line therapy or within 4 months after the last dose of first-line therapy&#xD;
               for metastatic or locally advanced disease.&#xD;
  &#xD;
            -  Presence of primary or metastatic disease, measurable per RECIST v1.1 on CT scan.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.&#xD;
  &#xD;
            -  Life expectancy of at least 3 months.&#xD;
  &#xD;
            -  Age ≥ 18 years in the US and Japan, and ≥ 19 years of age in Korea.&#xD;
  &#xD;
            -  Signed, written IRB-approved informed consent.&#xD;
  &#xD;
            -  Adequate organ function from specimens collected within 14 days prior to Day 1.&#xD;
  &#xD;
            -  For men and women of child-producing potential, the use of effective contraceptive&#xD;
               methods during the study and for 6 months after the last dose of TRK-950.&#xD;
  &#xD;
            -  All patients must sign a pre-screening consent to assess tumor tissue to determine&#xD;
               eligibility. Tumor tissue must be evaluable for CAPRIN-1 staining at a CLIA certified&#xD;
               laboratory and meet or exceed the cutoff value (30% at ≥ 2+ staining) as defined in&#xD;
               the expression level requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior history of treatment with ramucirumab or paclitaxel.&#xD;
  &#xD;
            -  HER2 positive gastric or GEJ adenocarcinoma.&#xD;
  &#xD;
            -  Major surgery within 28 days prior to randomization.&#xD;
  &#xD;
            -  Baseline corrected QT (QTc) interval of &gt; 470 msec for females and &gt; 450 msec for&#xD;
               males calculated using Fridericia's formula.&#xD;
  &#xD;
            -  New York Heart Association Class II - IV symptomatic congestive heart failure, or&#xD;
               symptomatic or poorly controlled cardiac arrhythmia.&#xD;
  &#xD;
            -  The patient has experienced any arterial thrombotic event, including myocardial&#xD;
               infarction, unstable angina, cerebrovascular accident, or transient ischemic attack,&#xD;
               within 3 months prior to randomization.&#xD;
  &#xD;
            -  The patient has a history of (non-infectious) pneumonitis that required steroids or&#xD;
               has current pneumonitis.&#xD;
  &#xD;
            -  Clinically symptomatic venous thromboembolism or treatment with anti-coagulants.&#xD;
  &#xD;
            -  Uncontrolled arterial hypertension ≥ 150 mmHg (systolic) or ≥ 90 mmHg (diastolic)&#xD;
               despite standard medical management.&#xD;
  &#xD;
            -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic&#xD;
               therapy.&#xD;
  &#xD;
            -  Pregnant or nursing women.&#xD;
  &#xD;
            -  Treatment with radiation therapy within 2 weeks, or treatment with chemotherapy,&#xD;
               immunotherapy, targeted therapy, or investigational therapy within 4 weeks prior to&#xD;
               randomization (within 2 weeks for Oral FU (S1 and capecitabine)).&#xD;
  &#xD;
            -  The patient has significant bleeding disorders, vasculitis, or had a significant&#xD;
               bleeding episode from the gastrointestinal tract within 3 months prior to&#xD;
               randomization.&#xD;
  &#xD;
            -  Clinically significant ascites, paracentesis in the last 3 months, or undergoes&#xD;
               regular paracentesis procedures.&#xD;
  &#xD;
            -  History of gastrointestinal perforation and/or fistulae within 6 months prior to&#xD;
               randomization.&#xD;
  &#xD;
            -  The patient has a serious or non-healing wound, peptic ulcer, or bone fracture within&#xD;
               28 days prior to randomization.&#xD;
  &#xD;
            -  The patient has a bowel obstruction, history or presence of inflammatory enteropathy&#xD;
               or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine&#xD;
               resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic&#xD;
               diarrhea.&#xD;
  &#xD;
            -  Known active infection with HIV, hepatitis B or hepatitis C. Patients with a history&#xD;
               of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.&#xD;
  &#xD;
            -  The patient is currently enrolled in or discontinued within the last 28 days from a&#xD;
               clinical trial involving an investigational product or non-approved use of a drug, or&#xD;
               concurrently enrolled in any other type of medical research judged not to be&#xD;
               scientifically or medically compatible with this study. Patients participating in&#xD;
               surveys or observational studies are eligible to participate in this 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_contact>
      <last_name>(Asia sites)Toray Contact for Clinical Trial Information</last_name>
      <phone>+81467-32-9948</phone>
      <email>npdd-clinical.toray.mb@mail.toray</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>(US sites) Contact for Clinical Trial Information</last_name>
      <phone>602 358 8300</phone>
      <email>vbauernschub@td2inc.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Osaka International Cancer Institute</name>
        <address>
          <city>Chuo Ku</city>
          <zip>541-8567</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <last_name>Site Coordinator</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gastric Cancer, Adenocarcinoma</keyword>
    <keyword>Gastroesophageal Junction Adenocarcinoma</keyword>
    <keyword>TRK-950</keyword>
    <keyword>CAPRIN-1</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma</mesh_term>
      <mesh_term>Stomach Neoplasms</mesh_term>
      <mesh_term>Esophageal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Ramucirumab</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038578
  org study id: 950GCV01
  nct id: NCT06038578
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This study will assess the efficacy, safety, optimal dose and ADA and NAbs development of
        TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX)
        as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal
        junction (GEJ) adenocarcinoma.
  This study will assess and compare the efficacy, safety, pharmacokinetics (PK), optimal dose
        and anti-drug antibodies (ADA) and neutralizing antibodies (NAbs) development of TRK-950 at
        two separate dose levels in combination with RAM + PTX as compared with RAM + PTX treatment
        alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma. The
        primary objective is progression free survival (PFS). Secondary objectives are overall
        survival, objective response rate, best overall response, duration of response, disease
        control rate, safety, pharmacokinetics, and immunogenicity of TRK-950 when used in
        combination with RAM+PTX.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression free Survival (PFS)
  time frame: Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months
  description: Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on Independent Central Review.
  measure: Overall survival (OS)
  time frame: Time from the date of randomization to the date of death due to any cause, up to approximately 24 months
  description: Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
  measure: Objective response rate (ORR)
  time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
  description: Objective response rate (ORR) is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review.
  measure: Progression free Survival (PFS)
  time frame: Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months
  description: Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on investigator assessment.
  measure: Objective response rate (ORR)
  time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
  description: Objective response rate (ORR) is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.
  measure: Best overall response (BOR)
  time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
  description: The best overall response is defined as the best overall response (BOR) recorded from the start of treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review based.
  measure: Best overall response (BOR)
  time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
  description: The best overall response is defined as the best overall response (BOR) recorded from the start of treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.
  measure: Disease control rate (DCR)
  time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
  description: Disease control rate (DCR) is defined as the proportion of participants who achieve a best overall response of complete response (CR), partial response (PR) or stable disease (SD) for a minimum of 6 weeks using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review based.
  measure: Disease control rate (DCR)
  time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
  description: Disease control rate (DCR) is defined as the proportion of participants who achieve a best overall response of complete response (CR), partial response (PR) or stable disease (SD) for a minimum of 6 weeks using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.
  measure: Duration of response (DoR)
  time frame: Time from initial response (CR or PR) to date of documented disease progression or death due to any cause, whichever occurs first, up to approximately 24 months
  description: Duration of response (DoR) is defined as the time from the initial response (CR or PR) until documented tumor progression or death from any cause based on Independent Central Review based.
  measure: Duration of response (DoR)
  time frame: Time from initial response (CR or PR) to date of documented disease progression or death due to any cause, whichever occurs first, up to approximately 24 months
  description: Duration of response (DoR) is defined as the time from the initial response (CR or PR) until documented tumor progression or death from any cause based on investigator assessment.
  measure: Incidence of Treatment-emergent Adverse Events (TEAE)
  time frame: From time subjects are enrolled up to 45 days after last study dose
  description: Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
  measure: Serious Adverse Events (SAEs)
  time frame: From time subjects are enrolled up to 45 days after last study dose
  description: Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
  measure: Adverse Events of Special Interest (AESI)
  time frame: From time subjects are enrolled up to 45 days after last study dose
  description: Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
  measure: Incidence of Discontinuation due to AE
  time frame: From time subjects are enrolled up to 45 days after last study dose
  description: Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
  measure: Incidence of Physical Examination Findings, Vital sign measurements, Standard clinical laboratory parameters, ECG parameters
  time frame: From time subjects signs informed consent form up to 45 days after last study dose
  measure: Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of TRK-950
  time frame: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
  measure: Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of TRK-950
  time frame: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
  measure: Pharmacokinetic Parameter of Area Under the Curve (AUC) of TRK-950
  time frame: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
  measure: Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of Ramucirumab
  time frame: Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)
  measure: Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of Ramucirumab
  time frame: Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)
  measure: Pharmacokinetic Parameter of Area Under the Curve (AUC) of Ramucirumab
  time frame: Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)
  measure: Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of Paclitaxel
  time frame: Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)
  measure: Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of Paclitaxel
  time frame: Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)
  measure: Pharmacokinetic Parameter of Area Under the Curve (AUC) of Paclitaxel
  time frame: Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)
  measure: Percentage of participants who are Anti-drug antibody (ADA)-Positive and Neutralizing antibodies (NAbs)
  time frame: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
  measure: Change from Baseline in Patient Reported Quality of Life assessed by the Questionnaire - Core questionnaire EORTC QLQ-C30 scores
  time frame: From Cycle 1 on day 1 through study completion, up to approximately 24 months (each cycle is 28days)
  description: The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life for cancer patients. It incorporates five functional scale (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
  measure: Change from Baseline in Patient Reported Quality of Life assessed by Questionnaire - EuroQOL Five Dimensions questionnaire 3L (EQ-5D-3L) scores
  time frame: From Cycle 1 on day 1 through study completion, up to approximately 24 months (each cycle is 28days)
  description: The EQ-5D questionnaire consists of the following five dimensions, each describing a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety/ Depression. The participants self-assess each dimension has three response levels of severity: no problems, some problems, extreme problems.
  arm group label: Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel
  arm group type: Experimental
  description: Participants who will be randomized to receive a 5 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
  arm group label: Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel
  arm group type: Experimental
  description: Participants who will be randomized to receive a 10 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
  arm group label: Arm C: Ramucirumab+Paclitaxel
  arm group type: Active Comparator
  description: Participants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
  intervention type: Biological
  intervention name: TRK-950
  description: 5 mg/kg or 10 mg/kg IV infusion over 60 minutes on Day 1, 8, 15 and 21 of each 28 day cycle
  arm group label: Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel
  arm group label: Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel
  intervention type: Drug
  intervention name: Ramucirumab
  description: 8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
  arm group label: Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel
  arm group label: Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel
  arm group label: Arm C: Ramucirumab+Paclitaxel
  other name: CYRAMZA®
  intervention type: Drug
  intervention name: Paclitaxel
  description: 80 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
  arm group label: Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel
  arm group label: Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel
  arm group label: Arm C: Ramucirumab+Paclitaxel
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: (Asia sites)Toray Contact for Clinical Trial Information
  phone: +81467-32-9948
  email: npdd-clinical.toray.mb@mail.toray
  last name: (US sites) Contact for Clinical Trial Information
  phone: 602 358 8300
  email: vbauernschub@td2inc.com
  facility: 
  contact: 
  country: Japan
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Stomach Neoplasms
  mesh term: Esophageal Neoplasms
  mesh term: Paclitaxel
  mesh term: Ramucirumab