<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/NCT02979392</url>
  </required_header>
  <id_info>
    <org_study_id>H1604-140-758</org_study_id>
    <nct_id>NCT02979392</nct_id>
  </id_info>
  <brief_title>Phase I Study of TENPA in Advanced Solid Cancer</brief_title>
  <official_title>A Prospective, Open-label, Dose Escalation (Part A), Cohort Expansion (Part B) Phase I Study to Investigate the Safety and to Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) in Patients With Advanced Solid Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yung-Jue Bang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the safety and to determine maximum tolerated&#xD;
      dose and recommended phase 2 dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)&#xD;
      in patients with advanced solid tumor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">May 2, 2016</start_date>
  <completion_date type="Actual">July 4, 2019</completion_date>
  <primary_completion_date type="Actual">July 4, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose limiting toxicity (DLT)</measure>
    <time_frame>at least one cycle of treatment (3 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)</measure>
    <time_frame>at least one cycle of treatment (3 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration [Cmax]</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve [AUC]</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate (RR)</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Phase I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A, Dose escalation TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) IV once every 3 weeks (Phase I starting dose 75 mg/m2) Part B, Expansion TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) IV once every 3 weeks (RP2D dose determined in part A)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)</intervention_name>
    <description>TENPA IV once every 3 weeks (Phase I starting dose 75 mg/m2)</description>
    <arm_group_label>Phase I</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing and able to provide written informed consent for voluntary participation in&#xD;
             the trial&#xD;
&#xD;
          2. Twenty years of age or older on the day of signing informed consent&#xD;
&#xD;
          3. Advanced solid tumors with no standard treatment available&#xD;
&#xD;
          4. Evaluable disease or have measurable lesion&#xD;
&#xD;
          5. ECOG performance score of 0 or 1&#xD;
&#xD;
          6. Life expectancy ≥ 12 weeks&#xD;
&#xD;
          7. Adequate organ and marrow function as defined below:&#xD;
&#xD;
             A. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (&gt; 1500 per mm3) B. Haemoglobin ≥ 8.0&#xD;
             g/dL C. Platelet count ≥ 100 x 109/L (&gt;100,000 per mm3) D. AST (SGOT)/ALT (SGPT) ≤ 2.5&#xD;
             x institutional ULN E. Serum bilirubin ≤ 2 x institutional upper limit of normal (ULN)&#xD;
             F. Serum creatinine ≤ 1.5 mg/dL&#xD;
&#xD;
          8. Adequate heart function A. QT interval corrected for heart rate (QTc) ≤ 480 ms&#xD;
&#xD;
          9. In the opinion of the investigator likely to have the willingness to comply with the&#xD;
             study protocol during and after the study period and capable of complying with it&#xD;
&#xD;
         10. Negative serum pregnancy test (β HCG) upon study entry and agree to use contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Uncontrolled CNS metastatic disease (radiographically unstable and symptomatic&#xD;
             disease). (note) Subjects with previously treated CNS metastases (surgery or&#xD;
             stereotactic brain radiation therapy) that are radiographically stable for at least 4&#xD;
             weeks are permitted to enroll. Subjects should not receive corticosteroids within 3&#xD;
             weeks prior to study enrollment.&#xD;
&#xD;
          2. History of leptomeningeal carcinomatosis; brain metastasis with seizure not controlled&#xD;
             with standard medical management.&#xD;
&#xD;
          3. Major surgery within 4 weeks: patient must have recovered from any effects of any&#xD;
             major surgery.&#xD;
&#xD;
          4. History of hematopoietic stem cell transplantation or solid organ transplantation&#xD;
&#xD;
          5. History of Gilbert's syndrome&#xD;
&#xD;
          6. Prior malignancy except:&#xD;
&#xD;
             Basal cell carcinoma and squamous cell carcinoma of the skin that has undergone&#xD;
             potentially curative surgery, in situ cervical cancer that has undergone potentially&#xD;
             curative surgery and had no evidence of recurrence at least in past 3 years, other&#xD;
             malignancy that has undergone curative surgery and had no evidence of disease at least&#xD;
             in past 5 years.&#xD;
&#xD;
          7. Significant cardiovascular disease, such as: history of myocardial infarction, acute&#xD;
             coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6&#xD;
             months; History or current evidence of clinically significant arrhythmia or conduction&#xD;
             disorder, except symptomatic congestive heart failure (CHR), atrial fibrillation, and&#xD;
             paroxysmal supraventricular tachycardia (PSVT)&#xD;
&#xD;
          8. Sustained uncontrolled hypertension&#xD;
&#xD;
          9. Test results indicating active infection with human immunodeficiency virus (HIR) or&#xD;
             hepatitis B or C, defined by positive serology testing (note) inactive hepatitis B&#xD;
             carrier on antiviral agents are permitted to enroll.&#xD;
&#xD;
         10. Neuromuscular disorder associated with CK elevation (eg. Inflammatory myopathies,&#xD;
             muscular dystrophy, amyotrophic lateral sclerosis, and spinobulbar muscular atrophy)&#xD;
&#xD;
         11. Uncontrolled intercurrent illness or symptoms including, but not limited to, ongoing&#xD;
             or active infection, bowel obstruction, psychiatric illness/social situations that&#xD;
             would limit compliance with study requirement.&#xD;
&#xD;
         12. Radiation therapy within 2 weeks of the first dose of study drug: patient must have&#xD;
             recovered from any effects of radiation therapy&#xD;
&#xD;
         13. Pregnant or breast feeding.&#xD;
&#xD;
         14. Female subjects of childbearing potential within the projected duration of the study,&#xD;
             starting with the screening visit through 30 days after the last dose of study drug.&#xD;
&#xD;
             Female of childbearing potential are defined as those who are not surgically sterile&#xD;
             (i.3., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or&#xD;
             who are not postmenopausal (defined as 12 months with no menses without an alternative&#xD;
             medical cause). Periodic abstinence, the rhythm method, and the withdrawal method are&#xD;
             not acceptable methods of birth control.&#xD;
&#xD;
         15. Non-sterilized males who are sexually active with a female partner of child bearing&#xD;
             potential from screening through 30 days after receipt of the final dose of study&#xD;
             drug.&#xD;
&#xD;
         16. Any medical, psychiatric or cognitive disorder that compromise the ability of the&#xD;
             subject to give informed consent, comply with the study protocol, and complete the&#xD;
             study.&#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>Yung-Jue Bang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Yung-Jue Bang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</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/NCT02979392
org study id: H1604-140-758
nct id: NCT02979392
lead sponsor: 
The purpose of this study is to investigate the safety and to determine maximum tolerated
      dose and recommended phase 2 dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)
      in patients with advanced solid tumor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose limiting toxicity (DLT)
time frame: at least one cycle of treatment (3 weeks)
measure: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
time frame: at least one cycle of treatment (3 weeks)
measure: Maximum Plasma Concentration [Cmax]
time frame: 3 weeks
measure: Area Under the Curve [AUC]
time frame: 3 weeks
measure: Response rate (RR)
time frame: 6 weeks
measure: Progression-free survival (PFS)
time frame: 6 weeks
arm group label: Phase I
arm group type: Experimental
description: Part A, Dose escalation TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) IV once every 3 weeks (Phase I starting dose 75 mg/m2) Part B, Expansion TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) IV once every 3 weeks (RP2D dose determined in part A)
intervention type: Drug
intervention name: TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)
description: TENPA IV once every 3 weeks (Phase I starting dose 75 mg/m2)
arm group label: Phase I
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yung-Jue Bang
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Yung-Jue Bang
investigator title: Professor
mesh term: Paclitaxel