<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/NCT02250885</url>
  </required_header>
  <id_info>
    <org_study_id>GCC-003</org_study_id>
    <nct_id>NCT02250885</nct_id>
  </id_info>
  <brief_title>KPT-330 to Treat Poorly Differentiated Lung and Gastroenteropancreatic Tumors</brief_title>
  <official_title>Investigator Initiated, Phase 2 Clinical Trial of Selinexor (KPT-330) for the Treatment of Poorly Differentiated Lung and Gastroenteropancreatic Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gabrail Cancer Center Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karyopharm Therapeutics Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Gabrail Cancer Center Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and&#xD;
      gastrointestinal and pancreatic neuroendocrine tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and&#xD;
      gastrointestinal and pancreatic neuroendocrine tumors in adult patients age &gt;/= to 18.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>Every 8 weeks from screening until documented disease progression or date of death, whichever occurs first, up to approximately 100 months.</time_frame>
    <description>To evaluate the efficacy of single agent Selinexor in patients with poorly differentiated lung and gastroenteropancreatic (GEP) neuroendocrine tumors (NET) as determined by overall response rate (ORR) including complete (CR) and partial (PR) response.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Carcinoma, Neuroendocrine</condition>
  <arm_group>
    <arm_group_label>Selinexor (KPT-330)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Selinexor will be taken orally at a starting dose of 50mg/m2 twice weekly on weeks 1, 2, and 3 of each 4 week cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor</intervention_name>
    <description>Selective Inhibitor fo Nuclear Export (SINE)</description>
    <arm_group_label>Selinexor (KPT-330)</arm_group_label>
    <other_name>KPT-330</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent in accordance with federal, local, and institutional&#xD;
             guidelines&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Patients must have a tissue diagnosis of any of the following:&#xD;
&#xD;
               -  Small cell lung cancer (SCLC) or poorly differentiated gastroenteropancreatic&#xD;
                  neuroendocrine tumor (GEP-NET)&#xD;
&#xD;
               -  Poorly differentiated metastatic neuroendocrine tumors of unknown primary origin&#xD;
&#xD;
          -  Measurable disease: Any primary and/or metastatic mass reproducibly measurable in one&#xD;
             or two diameters by RECIST 1.1 parameters by cat scan (CT) scan.&#xD;
&#xD;
          -  Objective evidence of tumor progression within 4 months prior to study entry, as&#xD;
             defined by serial cat scan (CT) per RECIST 1.1 criteria. (At least a 20% increase in&#xD;
             the sum of diameters of target lesions. In addition, the sum must also demonstrate an&#xD;
             absolute increase of at least 5 mm. The appearance of one or more new lesions is also&#xD;
             considered progression).&#xD;
&#xD;
          -  Patients must have received at least one prior line of chemotherapy and must have&#xD;
             exhausted any other standard-of-care treatment option.&#xD;
&#xD;
          -  Prior radiation and surgery is allowed. At least 3 weeks should have elapsed from&#xD;
             surgery, chemotherapy, hepatic embolization/ chemoembolization or radioactive isotopes&#xD;
             (i.e. Yttrium 90). In any case, disease progression must be documented after&#xD;
             treatment.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1&#xD;
&#xD;
          -  Concomitant octreotide treatment for carcinoid syndrome is allowed for patients whose&#xD;
             tumor has progressed while on octreotide. Patients must have been on a stable dose of&#xD;
             octreotide two weeks prior to enrollment and must remain on a stable dose during the&#xD;
             study.&#xD;
&#xD;
          -  Hematological function:&#xD;
&#xD;
               -  Total white blood cell count (WBC) &gt; 2,000/mm³&#xD;
&#xD;
               -  Absolute neutrophil (ANC) &gt; 1,000/mm³&#xD;
&#xD;
               -  Platelet &gt;100,000mm³&#xD;
&#xD;
          -  Adequate hepatic function within 14 days prior to C1D1: total direct bilirubin &lt;2&#xD;
             times the upper limit of normal (ULN; 1.0 mg/dL) and alanine aminotransferase (ALT)&#xD;
             &lt;2.5 times ULN (30 U/L). In the case of known (radiological and/or biopsy documented)&#xD;
             liver metastasis, ALT &lt;5.0 times ULN is acceptable.&#xD;
&#xD;
          -  Adequate renal function within 7 days prior to C1D1: estimated creatinine clearance of&#xD;
             ≥ 30 mL/min, calculated using the formula of Cockcroft and Gault: (140-Age) • Mass&#xD;
             (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female.&#xD;
&#xD;
          -  Blood electrolytes should be within the following normal limits:&#xD;
&#xD;
        Bicarbonate (total) 18-30 mEq/L Sodium 135-147 mEq/L Potassium 3.5-5.5 mEq/L Phosphorus&#xD;
        1.8-2.3 mEq/L Magnesium 1.5-3.0 mEq/L Chloride 98-106 mEq/L Calcium (total) 4.5-5.5 mEq/L&#xD;
&#xD;
          -  Female patients of child-bearing potential must agree to use dual methods of&#xD;
             contraception and have a negative serum pregnancy test at screening, and male patients&#xD;
             must use an effective barrier method of contraception if sexually active with a female&#xD;
             of child-bearing potential. Acceptable methods of contraception are condoms with&#xD;
             contraceptive foam, oral, implantable or injectable contraceptives, contraceptive&#xD;
             patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is&#xD;
             surgically sterilized or post-menopausal. For both male and female patients, effective&#xD;
             methods of contraception must be used throughout the study and for three months&#xD;
             following the last dose.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant or lactating&#xD;
&#xD;
          -  Patients with the following tumor types: lung carcinoid, pheochromocytomas,&#xD;
             paragangliomas, medullary thyroid carcinomas, any other tumors with neuroendocrine&#xD;
             features not listed in the inclusion criteria&#xD;
&#xD;
          -  Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤3 weeks&#xD;
             prior to C1D1&#xD;
&#xD;
          -  Major surgery ≤3 weeks prior to C1D1&#xD;
&#xD;
          -  Unstable cardiovascular function:&#xD;
&#xD;
               -  Congestive heart failure (CHF) of NYHA Class ≥3 OR&#xD;
&#xD;
               -  Myocardial infarction (MI) within 3 months&#xD;
&#xD;
          -  Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals&#xD;
             within one week prior to first dose; patients with controlled infection or on&#xD;
             prophylactic antibiotics are permitted in the study&#xD;
&#xD;
          -  Known to be human immunodeficiency virus (HIV) seropositive&#xD;
&#xD;
          -  Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C&#xD;
             virus (HCV RNA) or HBsAg (HBV surface antigen)&#xD;
&#xD;
          -  Any underlying condition that would significantly interfere with the absorption of an&#xD;
             oral medication&#xD;
&#xD;
          -  Patients who have active central nervous system (CNS) malignancy. Asymptomatic small&#xD;
             lesions are not considered active. Treated lesions may be considered inactive if they&#xD;
             are stable for at least 3 months. Patient with malignant cells in their cerebrospinal&#xD;
             fluid (CSF) without CNS symptom may be included.&#xD;
&#xD;
          -  Serious psychiatric or medical conditions that could interfere with treatment&#xD;
&#xD;
          -  Patients with coagulation problems and active bleeding in the last month (peptic&#xD;
             ulcer, epistaxis, spontaneous bleeding)&#xD;
&#xD;
          -  Patients with signs of gastrointestinal obstruction or uncontrolled vomiting or&#xD;
             diarrhea (&gt;3 episodes/week) with electrolyte abnormalities&#xD;
&#xD;
          -  Concurrent therapy with approved or investigational anticancer therapeutic agents&#xD;
             other than glucocorticoids&#xD;
&#xD;
          -  Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1&#xD;
             day 1&#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_official>
    <last_name>Nashat Y Gabrail, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gabrail Cancer Center Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gabrail Cancer Center Research</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 13, 2019</last_update_submitted>
  <last_update_submitted_qc>September 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Selinexor</keyword>
  <keyword>phase 2</keyword>
  <keyword>Gabrail</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Neuroendocrine</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/NCT02250885
org study id: GCC-003
nct id: NCT02250885
lead sponsor: 
collaborator: 
has dmc: No
Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and
      gastrointestinal and pancreatic neuroendocrine tumors.
Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and
      gastrointestinal and pancreatic neuroendocrine tumors in adult patients age >/= to 18.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate
time frame: Every 8 weeks from screening until documented disease progression or date of death, whichever occurs first, up to approximately 100 months.
description: To evaluate the efficacy of single agent Selinexor in patients with poorly differentiated lung and gastroenteropancreatic (GEP) neuroendocrine tumors (NET) as determined by overall response rate (ORR) including complete (CR) and partial (PR) response.
arm group label: Selinexor (KPT-330)
arm group type: Experimental
description: Selinexor will be taken orally at a starting dose of 50mg/m2 twice weekly on weeks 1, 2, and 3 of each 4 week cycle.
intervention type: Drug
intervention name: Selinexor
description: Selective Inhibitor fo Nuclear Export (SINE)
arm group label: Selinexor (KPT-330)
other name: KPT-330
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nashat Y Gabrail, MD
role: Principal Investigator
affiliation: Gabrail Cancer Center Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Neuroendocrine
sharing ipd: No