<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/NCT03817411</url>
  </required_header>
  <id_info>
    <org_study_id>EOC315B2101</org_study_id>
    <nct_id>NCT03817411</nct_id>
  </id_info>
  <brief_title>Telatinib in Combination With Capecitabine/ Oxaliplatin in 1st Line Gastric or GEJ Cancer</brief_title>
  <official_title>A Phase II Randomized Trial of Telatinib in Combination With Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin as First-Line Therapy in Patients With HER2-negative Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taizhou EOC Pharma Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai East Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taizhou EOC Pharma Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine&#xD;
      and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib&#xD;
      combination in terms of progression-free survival (PFS) in patients previously untreated for&#xD;
      advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a Phase 2, prospective, double-blind, randomized, comparative, multicenter&#xD;
      trial in patients with advanced HER2 negative adenocarcinoma of the stomach or&#xD;
      Gastroesophageal Junction which has progressed after resection and adjuvant or neoadjuvant&#xD;
      therapy, or is unresectable or metastatic at time of first diagnosis. a total of&#xD;
      approximately 90 patients will be enrolled and randomized into Telatinib combined with&#xD;
      Capecitabine and Oxaliplatin or chemotherapy combined with placebo. All patients will be&#xD;
      treated until progressive disease (radiologically documented or symptomatic deterioration) or&#xD;
      the occurrence of unacceptable toxicity, withdrawal of consent or investigator's judgment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Anticipated">January 25, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ORR</measure>
    <time_frame>24 months</time_frame>
    <description>the proportion of patients with complete response (CR) or partial response (PR) among all patients assessed per RESIST v1.1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>24 months</time_frame>
    <description>Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CBR</measure>
    <time_frame>24 months</time_frame>
    <description>Clinical Benefit Rate, defined as CR+PR+SD≥ 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>24 months</time_frame>
    <description>the proportion of patients who had a best response rating of complete response, partial response, or stable disease</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Telatinib+Capecitabine+Oxaliplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive Telatinib orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebos+Capecitabine+Oxaliplatin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive placebo orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telatinib</intervention_name>
    <description>300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.</description>
    <arm_group_label>Telatinib+Capecitabine+Oxaliplatin</arm_group_label>
    <other_name>EOC315</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).</description>
    <arm_group_label>Placebos+Capecitabine+Oxaliplatin</arm_group_label>
    <arm_group_label>Telatinib+Capecitabine+Oxaliplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles.</description>
    <arm_group_label>Placebos+Capecitabine+Oxaliplatin</arm_group_label>
    <arm_group_label>Telatinib+Capecitabine+Oxaliplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.</description>
    <arm_group_label>Placebos+Capecitabine+Oxaliplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female at least 18 and &lt;75 years old at the time of screening.&#xD;
&#xD;
          2. Histologically or cytologically confirmed unresectable locally advanced or metastatic&#xD;
             HER2 negative (or HER2 status unknown), gastric or gastro-oesophageal junction&#xD;
             adenocarcinoma.&#xD;
&#xD;
          3. Measurable or evaluable lesion as defined by RECIST v1.1.&#xD;
&#xD;
          4. No prior treatment for advanced disease. Adjuvant or neoadjuvant chemotherapy must be&#xD;
             stopped at least for 6 months.&#xD;
&#xD;
          5. Prior surgery and/or radiotherapy stopped for at least 4 weeks.&#xD;
&#xD;
          6. ECOG Performance Status 0-1.&#xD;
&#xD;
          7. Life expectancy of at least 3 months.&#xD;
&#xD;
          8. Adequate bone marrow function as evidenced by meeting all of the following&#xD;
             requirements:&#xD;
&#xD;
               1. Absolute neutrophil count &gt; 1.5 × 10 E+9/L without the use of hematopoietic&#xD;
                  growth factors&#xD;
&#xD;
               2. Platelet count &gt; 90 ×10 E+9/L without the need for transfusion in the 2 weeks&#xD;
                  prior the first dose&#xD;
&#xD;
               3. Hemoglobin &gt;90 g/L without the need for transfusion in the 2 weeks prior the&#xD;
                  first dose&#xD;
&#xD;
          9. Adequate hepatic function as evidenced by meeting all of the following requirements:&#xD;
&#xD;
               1. Serum total bilirubin ≤1.5 x upper limit of normal (ULN) (biliary drainage is&#xD;
                  allowed for biliary obstruction)&#xD;
&#xD;
               2. Serum albumin levels ≥3.0 g/dL&#xD;
&#xD;
               3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and and&#xD;
                  alkaline phosphatase (ALP): ≤3.0 x upper limit of normal (ULN) (≤5 x ULN if liver&#xD;
                  metastases are present and if liver and/or bone metastases ALP ≤ 5 × ULN.)&#xD;
&#xD;
         10. Adequate renal function as evidenced by&#xD;
&#xD;
               1. serum creatinine ≤1.5 x ULN and creatinine clearance of ≥50 mL/min&#xD;
                  (Cockcroft-Gault formula).&#xD;
&#xD;
               2. Urine dipstick for proteinuria of less than 2+ (other ways of urinalysis are also&#xD;
                  acceptable); if urine dipstick is ≥ 2+, proteinuria must be &lt; 2 g in 24 hours.&#xD;
&#xD;
         11. Prothrombin time (PT) or activated partial thromboplastin time (APTT) and&#xD;
             International Normalized Ratio (INR) ≤1.5 x ULN.&#xD;
&#xD;
         12. Recovered from the effects of any prior surgery, radiotherapy or other anti-neoplastic&#xD;
             adjuvant therapy. Unresolved toxicity &gt; Grade 1 (except alopecia) from previous&#xD;
             anticancer therapy (including radiotherapy) is accepted&#xD;
&#xD;
         13. If female of childbearing potential, the patient must present with a negative urine&#xD;
             pregnancy test and agrees to employ adequate birth control measures for at least 90&#xD;
             days after the duration of the study&#xD;
&#xD;
         14. Male who are not sterile agrees to take effective contraception for at least 90 days&#xD;
             after the last dose of drug and avoid donating sperm at the same time period.&#xD;
&#xD;
         15. Ability to swallow pills and no major intestinal surgery.&#xD;
&#xD;
         16. Able to understand and sign an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypertension and unable to be controlled within normal level following treatment of&#xD;
             anti-hypertension agents (systolic blood pressure &gt; 150 mmHg, diastolic blood pressure&#xD;
             &gt; 100 mmHg).&#xD;
&#xD;
          2. Active and uncontrolled central nervous system (CNS) metastases .&#xD;
&#xD;
          3. During the screening and study period, standard dose of anticoagulant or thrombolytic&#xD;
             drugs are used for treatment;&#xD;
&#xD;
          4. History of any second malignancy in the last 5 years; patients with prior history of&#xD;
             in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with other&#xD;
             malignancies are eligible if they have been continuously disease free for at least 5&#xD;
             years.&#xD;
&#xD;
          5. Evidence of tumor invasion of major blood vessels by images(including complete&#xD;
             proximity, surrounding or extending into the main vascular lumen, such as the&#xD;
             pulmonary artery or the superior vena cava), and the investigator judged that it was&#xD;
             not suitable for enrollment.&#xD;
&#xD;
          6. A significant thrombotic or hemorrhagic event ≤ 6 months prior to Screening (includes&#xD;
             hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, severe epistaxis&#xD;
             or vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial&#xD;
             infarction, angina, and uncontrolled coronary artery disease).&#xD;
&#xD;
          7. History of active gastroduodenal ulcer, abdominal fistula as well as&#xD;
             nongastrointestinal fistula, gastrointestinal perforation or intraabdominal abscess&#xD;
             within 6 months prior to screening.&#xD;
&#xD;
          8. Significant cardiac conduction abnormalities, including a history of long QTc syndrome&#xD;
             and/or pacemaker.New York Heart Association Class III or IV congestive heart failure,&#xD;
             ventricular arrhythmias&#xD;
&#xD;
          9. Exposure to any other investigational or commercial anticancer agents or therapies&#xD;
             (Chinese herbal medicines e.g) administered with the intention to treat malignancy&#xD;
             within 28 days.&#xD;
&#xD;
         10. Active infection or an unexplained fever during screening visits or on the first&#xD;
             scheduled day of dosing (at the discretion of the Investigator, patients with tumor&#xD;
             fever may be enrolled), which in the investigator's opinion might compromise the&#xD;
             patient's participation in the trial or affect the trial outcome.&#xD;
&#xD;
         11. Positive test or known history of for human immunodeficiency virus (HIV), active&#xD;
             hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody) or syphilis (syphilis antibody)&#xD;
&#xD;
         12. If female, the patient is pregnant or lactating at the time of enrollment.&#xD;
&#xD;
         13. Known hypersensitivity to any of the components of fluoropyrimidines or platinum&#xD;
             cmpounds.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Li, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Easter Hospital, Dpt. of Clinical Oncology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tian Shu Liu, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Fudan Zhongshan Hospital, Dpt. of Clinical Oncology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peng Wang, M.S.</last_name>
    <phone>18606193900</phone>
    <email>peng.wang@eocpharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jie Li, M.S.</last_name>
    <phone>18951813306</phone>
    <email>jie.li@eocpharma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Easter Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Li, M.D.</last_name>
      <phone>021-20334612</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>May 3, 2019</last_update_submitted>
  <last_update_submitted_qc>May 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</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>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03817411
org study id: EOC315B2101
nct id: NCT03817411
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine
      and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib
      combination in terms of progression-free survival (PFS) in patients previously untreated for
      advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.
This trial is a Phase 2, prospective, double-blind, randomized, comparative, multicenter
      trial in patients with advanced HER2 negative adenocarcinoma of the stomach or
      Gastroesophageal Junction which has progressed after resection and adjuvant or neoadjuvant
      therapy, or is unresectable or metastatic at time of first diagnosis. a total of
      approximately 90 patients will be enrolled and randomized into Telatinib combined with
      Capecitabine and Oxaliplatin or chemotherapy combined with placebo. All patients will be
      treated until progressive disease (radiologically documented or symptomatic deterioration) or
      the occurrence of unacceptable toxicity, withdrawal of consent or investigator's judgment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: ORR
time frame: 24 months
description: the proportion of patients with complete response (CR) or partial response (PR) among all patients assessed per RESIST v1.1.
measure: PFS
time frame: 24 months
description: Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
measure: CBR
time frame: 24 months
description: Clinical Benefit Rate, defined as CR+PR+SD≥ 24 weeks
measure: DCR
time frame: 24 months
description: the proportion of patients who had a best response rating of complete response, partial response, or stable disease
arm group label: Telatinib+Capecitabine+Oxaliplatin
arm group type: Active Comparator
description: Patients receive Telatinib orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.
arm group label: Placebos+Capecitabine+Oxaliplatin
arm group type: Placebo Comparator
description: Patients receive placebo orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.
intervention type: Drug
intervention name: Telatinib
description: 300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
arm group label: Telatinib+Capecitabine+Oxaliplatin
other name: EOC315
intervention type: Drug
intervention name: Capecitabine
description: 1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).
arm group label: Placebos+Capecitabine+Oxaliplatin
arm group label: Telatinib+Capecitabine+Oxaliplatin
intervention type: Drug
intervention name: Oxaliplatin
description: 130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles.
arm group label: Placebos+Capecitabine+Oxaliplatin
arm group label: Telatinib+Capecitabine+Oxaliplatin
intervention type: Drug
intervention name: Placebos
description: 300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
arm group label: Placebos+Capecitabine+Oxaliplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jin Li, M.D.
role: Study Chair
affiliation: Shanghai Easter Hospital, Dpt. of Clinical Oncology
last name: Tian Shu Liu, M.D.
role: Study Chair
affiliation: Shanghai Fudan Zhongshan Hospital, Dpt. of Clinical Oncology
last name: Peng Wang, M.S.
phone: 18606193900
email: peng.wang@eocpharma.com
last name: Jie Li, M.S.
phone: 18951813306
email: jie.li@eocpharma.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Capecitabine
mesh term: Oxaliplatin
sharing ipd: Undecided