<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/NCT03301805</url>
  </required_header>
  <id_info>
    <org_study_id>RGC-1502-01</org_study_id>
    <nct_id>NCT03301805</nct_id>
  </id_info>
  <brief_title>A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer</brief_title>
  <official_title>A Phase II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Gemcitabine Monotherapy in Patients With Advanced Inoperable or Metastatic Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rgene Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American BriVision Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rgene Corporation</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>
      The primary purpose of this study is to determine the safety and recommended dose level (RDL)&#xD;
      of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.The&#xD;
      secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with&#xD;
      Gemcitabine monotherapy at the recommended dose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2023</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2025</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Study Objectives Part I To determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.&#xD;
Part II To assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part I: Dose-limiting toxicity (DLT) observation</measure>
    <time_frame>4 weeks (1 cycle)</time_frame>
    <description>Presence or absence of dose-limiting toxicity (DLT) related to BLEX 404 Oral Liquid for each patient during first cycle of Gemcitabine monotherapy to determine the recommended dose level (RDL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: Overall response rate (PR + CR)</measure>
    <time_frame>12 weeks (3 cycle)</time_frame>
    <description>Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Gemcitabine monotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part II: Overall benefit rate (CR + PR + SD)</measure>
    <time_frame>12 weeks (3 cycle)</time_frame>
    <description>1. Overall benefit rate (CR + PR + SD) after at least 3 cycles of combination use of BLEX 404 plus Gemcitabine monotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: Incidence of grade 3/4 hematological toxicity</measure>
    <time_frame>4 weeks (1 cycle)</time_frame>
    <description>Rate of grade 3/4 hematological toxicity of each cycle.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>BLEX 404 Oral Liquid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During Phase I study (dose escalation), a standard 3+3 design will be followed, and the dose range is 3 to 10 mg/kg BID. The recommended dose level (RDL) for the Phase II study is defined as the dose level with 0 to 1 DLT observed during cycle I of Gemcitabine monotherapy among 6 patients in the Phase I study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLEX 404</intervention_name>
    <description>BLEX 404 Oral Liquid is administered twice daily during the Gemcitabine monotherapy period. The dose of Gemcitabine 1,000 mg/m2 IV fusion at Day 1, 8, 15 of every cycle&#xD;
28 days a cycle.</description>
    <arm_group_label>BLEX 404 Oral Liquid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged 20 - 80 years old at the time of signing the ICF.&#xD;
&#xD;
          2. Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed&#xD;
             with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or&#xD;
             adjuvant gemcitabine are acceptable, unless exclusion criteria met).&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status of 1 to 2.&#xD;
&#xD;
          4. Adequate hematologic function defined as: absolute neutrophil count (ANC) &gt;= 2,000/μL;&#xD;
             platelets count &gt;= 100,000/μL; hemoglobin must be &gt;= 10 g/dL (can be corrected by&#xD;
             growth factor or transfusion).&#xD;
&#xD;
          5. Adequate hepatic function defined as: serum bilirubin =&lt; 1.5-fold upper limit of&#xD;
             normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and&#xD;
             alkaline phosphatase (ALP) =&lt; 3-fold ULN (5-fold ULN if liver metastasis is observed).&#xD;
&#xD;
          6. Adequate renal function with: serum creatinine =&lt; 1.3 mg/dL or calculated creatinine&#xD;
             clearance &gt;= 60 mL/minute according to the Cockcroft and Gault formula.&#xD;
&#xD;
          7. At least one measurable disease according to the Response Evaluation Criteria in Solid&#xD;
             Tumors (RECIST) version 1.1.&#xD;
&#xD;
          8. Women must be either of non-child bearing potential, or women with child-bearing&#xD;
             potential agree to use effective a highly contraceptive method or a contraceptive&#xD;
             implant, exception of hormonal contraception (estrogen/progesterone), during treatment&#xD;
             from time of Screening Visit and after cessation of therapy at least 3 months.&#xD;
&#xD;
          9. Planning to receive Gemcitabine monotherapy.&#xD;
&#xD;
         10. Willing and able to comply with all aspects of the treatment protocol.&#xD;
&#xD;
         11. Provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with following treatment prior to Gemcitabine monotherapy: chemotherapy,&#xD;
             immunotherapy, or biologic systemic anticancer therapy within 28 days of study entry.&#xD;
&#xD;
          2. Pancreatic patients with prior history of Gemcitabine chemotherapy.&#xD;
&#xD;
          3. Women who are pregnant or breastfeeding.&#xD;
&#xD;
          4. Patients with brain metastasis.&#xD;
&#xD;
          5. Patients with bone metastasis alone.&#xD;
&#xD;
          6. Patients with autoimmune disease that requires systemic steroids or immunosuppression&#xD;
             agents.&#xD;
&#xD;
          7. Current enrollment in another clinical study or used any investigational drug or&#xD;
             device within the past 28 days preceding informed consent.&#xD;
&#xD;
          8. Known history of human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          9. Existing anticancer treatment-related toxicities of Grades &gt;= 2 (except for alopecia&#xD;
             and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE&#xD;
             v4.03).&#xD;
&#xD;
         10. Patients with an active infection requiring systemic therapy.&#xD;
&#xD;
         11. Patients are hepatitis C virus (HCV) carrier, and/or with active viral disease which&#xD;
             is defined as hepatitis B virus (HBV) carrier with HBV DNA &gt; 2,000 IU/ml plus AST and&#xD;
             ALT &gt; 3-fold ULN.&#xD;
&#xD;
         12. History of concomitant medical conditions or infectious diseases that, in the opinion&#xD;
             of the investigator, would compromise the patient's ability to safely complete the&#xD;
             study.&#xD;
&#xD;
         13. Ascertained hypersensitivity to investigational product, Gemcitabine or any of the&#xD;
             excipients used in the study.&#xD;
&#xD;
         14. Uncontrolled nausea or vomiting or any symptom that would prevent the ability to&#xD;
             comply with daily BLEX 404 Oral Liquid treatment.&#xD;
&#xD;
         15. Judged to be not applicable to this study by investigator such as difficulty of&#xD;
             follow-up observation, psychiatric disorder, with any other serious diseases/medical&#xD;
             history.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gi-Ming Lai, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Municipal Wanfang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frank C. Liu</last_name>
    <phone>+886-2-87518701</phone>
    <phone_ext>214</phone_ext>
    <email>liu3763@bioliteinc.com</email>
  </overall_contact>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_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/NCT03301805
org study id: RGC-1502-01
nct id: NCT03301805
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of this study is to determine the safety and recommended dose level (RDL)
      of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.The
      secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with
      Gemcitabine monotherapy at the recommended dose.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Study Objectives Part I To determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.
Part II To assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.
primary purpose: Treatment
masking: None (Open Label)
measure: Part I: Dose-limiting toxicity (DLT) observation
time frame: 4 weeks (1 cycle)
description: Presence or absence of dose-limiting toxicity (DLT) related to BLEX 404 Oral Liquid for each patient during first cycle of Gemcitabine monotherapy to determine the recommended dose level (RDL).
measure: Part II: Overall response rate (PR + CR)
time frame: 12 weeks (3 cycle)
description: Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Gemcitabine monotherapy.
measure: Part II: Overall benefit rate (CR + PR + SD)
time frame: 12 weeks (3 cycle)
description: 1. Overall benefit rate (CR + PR + SD) after at least 3 cycles of combination use of BLEX 404 plus Gemcitabine monotherapy.
measure: Part II: Incidence of grade 3/4 hematological toxicity
time frame: 4 weeks (1 cycle)
description: Rate of grade 3/4 hematological toxicity of each cycle.
arm group label: BLEX 404 Oral Liquid
arm group type: Experimental
description: During Phase I study (dose escalation), a standard 3+3 design will be followed, and the dose range is 3 to 10 mg/kg BID. The recommended dose level (RDL) for the Phase II study is defined as the dose level with 0 to 1 DLT observed during cycle I of Gemcitabine monotherapy among 6 patients in the Phase I study.
intervention type: Drug
intervention name: BLEX 404
description: BLEX 404 Oral Liquid is administered twice daily during the Gemcitabine monotherapy period. The dose of Gemcitabine 1,000 mg/m2 IV fusion at Day 1, 8, 15 of every cycle
28 days a cycle.
arm group label: BLEX 404 Oral Liquid
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gi-Ming Lai, M.D.
role: Principal Investigator
affiliation: Taipei Municipal Wanfang Hospital
last name: Frank C. Liu
phone: +886-2-87518701
phone ext: 214
email: liu3763@bioliteinc.com
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: No