<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/NCT02215850</url>
  </required_header>
  <id_info>
    <org_study_id>OZM-055/SLC0111-14-C01</org_study_id>
    <nct_id>NCT02215850</nct_id>
  </id_info>
  <brief_title>Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours</brief_title>
  <official_title>A Phase I, Multi-center, Open-label, Study to Investigate the Safety, Tolerability and Pharmacokinetic of SLC-0111 in Subjects With Advanced Solid Tumours</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Welichem Biotech Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ozmosis Research Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Welichem Biotech Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      SLC-0111 is a selective, small molecule, inhibitor of carbonic anhydrase (CA) IX and is in&#xD;
      development for the treatment of solid tumours over-expressing CA IX. CAIX, a transmembrane&#xD;
      metalloenzyme, is overexpressed on extracellular surfaces of hypoxic tumour cells but its&#xD;
      expression is highly restricted in normal tissue. CAIX is a functional regulator of processes&#xD;
      critical for tumour growth and metastasis, including pH regulation, survival, migration and&#xD;
      invasion.&#xD;
&#xD;
      This prospective single arm study will evaluate the safety of SLC-0111 given once daily in 28&#xD;
      day cycles in subjects with advanced solid tumours. The intent of this research study is to&#xD;
      find our more information such as: the highest dose of SLC-0111 that can be given safely, the&#xD;
      side effect it may cause, to examine how the body affects the study drug concentration in the&#xD;
      blood (pharmacokinetics or PK), and to gain some information on its effectiveness in treating&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Number of participants with adverse events</measure>
    <time_frame>1 year. Subjects will continue to receive SLC-0111 for multiple cycles of 28 days if they are receiving benefit from therapy.</time_frame>
    <description>To evaluate the safety and tolerability of SLC-0111, administered once daily, in subjects with advanced solid tumours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of SLC-0111</measure>
    <time_frame>1 year.</time_frame>
    <description>Changes in AUC over time in subjects taking SLC-0111 once daily.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Solid Tumours</condition>
  <arm_group>
    <arm_group_label>SLC-0111</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SLC-0111</intervention_name>
    <arm_group_label>SLC-0111</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females aged ≥ 18 years old.&#xD;
&#xD;
          2. Able and willing to provide written informed consent and to comply with the study&#xD;
             protocol and procedures.&#xD;
&#xD;
          3. Histological or cytological evidence of advanced and/or metastatic or unresectable&#xD;
             tumour(s) for which standard curative measures do not exist.&#xD;
&#xD;
          4. Recovery to ≤ Grade 1 from the effects (excluding alopecia) of any prior therapy for&#xD;
             their malignancies.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1&#xD;
&#xD;
          6. Life expectancy greater than 3 months in the Investigator's opinion.&#xD;
&#xD;
          7. The following time must have elapsed between previous therapy for cancer and first&#xD;
             administration of SLC-0111:&#xD;
&#xD;
               -  At least 4 weeks since previous cancer-directed therapy (cytotoxic agents,&#xD;
                  targeted therapy including monoclonal antibody therapy, immunotherapy, hormonal&#xD;
                  therapy, and prior radiotherapy).&#xD;
&#xD;
               -  At least 4 weeks or five times the elimination half-life (whichever is shortest)&#xD;
                  of any investigational drug/biologic or combination product prior to first dose&#xD;
                  of study treatment.&#xD;
&#xD;
               -  At least 3 months since prior interferon therapy.&#xD;
&#xD;
               -  At least 4 weeks since any major surgery&#xD;
&#xD;
               -  At least 12 weeks since any incidence of severe gastrointestinal bleeding.&#xD;
&#xD;
          8. Adequate renal function:&#xD;
&#xD;
             • Creatinine ≤1.5 times upper limit of normal (ULN) or calculated creatinine clearance&#xD;
             (CrCl) using the Cockcroft Gault formula ≥60 mL/min, or measured CrCl ≥60 mL/min.&#xD;
&#xD;
          9. Adequate hepatic function:&#xD;
&#xD;
               -  Serum bilirubin ≤1.5 times upper limit of normal (ULN)&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN&#xD;
                  (≤5 x ULN if liver lesions present [i.e. liver metastasis or primary tumour of&#xD;
                  the liver for hepatocellular carcinoma (HCC]).&#xD;
&#xD;
         10. Adequate bone marrow function:&#xD;
&#xD;
               -  Absolute neutrophil count ≥1.5 x 109/L&#xD;
&#xD;
               -  Platelets ≥100 x 109/L&#xD;
&#xD;
               -  Haemoglobin ≥90 g/L&#xD;
&#xD;
         11. Adequate coagulation tests: international normalised ratio (INR) ≤1.5 x ULN.&#xD;
&#xD;
         12. Corrected QT interval (QTcB) &lt; 470 ms&#xD;
&#xD;
         13. Ability to take oral liquid medication&#xD;
&#xD;
         14. Negative urine pregnancy test within 14 days prior to the first dose of study therapy&#xD;
             for women of child-bearing potential, defined as a sexually mature woman who has not&#xD;
             undergone a hysterectomy/oophorectomy or who has not been naturally postmenopausal for&#xD;
             at least 24 consecutive months (i.e., who has had menses any time in the preceding 24&#xD;
             consecutive months).&#xD;
&#xD;
         15. Sexually-active women of child-bearing potential and sexually-active male subjects&#xD;
             with a female partner of child-bearing potential or pregnant must agree to use&#xD;
             acceptable double-barrier methods of contraception to avoid pregnancy from screening,&#xD;
             for the duration of the study, and for 4 months after the last dose of study drug&#xD;
             (Rhythm methods and/or abstinence will not be considered as highly effective methods&#xD;
             of birth control).&#xD;
&#xD;
         16. Subjects must agree not to donate gametes (i.e. sperms and eggs) during the study and&#xD;
             for 4 months following their last dose of SLC-0111.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior treatment with any drugs known to inhibit hypoxia (drugs that function under&#xD;
             hypoxia and drugs that target cells in hypoxic regions are allowed).&#xD;
&#xD;
          2. Females who are pregnant, planning to become pregnant or breastfeeding.&#xD;
&#xD;
          3. Known central nervous system metastasis that is symptomatic and/or requires treatment.&#xD;
             Radiographically stable lesions for 3 months prior to enrollment that were previously&#xD;
             treated with steroids are permitted as long as they are not currently being treated&#xD;
             with steroids.&#xD;
&#xD;
          4. History of myocardial infarction, unstable angina, congestive heart failure (New York&#xD;
             Heart Association class III/IV), cerebrovascular accident, transient ischaemic attack,&#xD;
             limb claudication at rest in the 6 months prior to the first administration of&#xD;
             SLC-0111, or ongoing symptomatic dysrhythmias, or uncontrolled atrial or ventricular&#xD;
             arrhythmias, or uncontrolled hypertension defined as systolic blood pressure ≥150 mmHg&#xD;
             or diastolic blood pressure ≥90 mmHg, or left ventricular ejection fraction (LVEF)&#xD;
             &lt;50%.&#xD;
&#xD;
          5. Any condition or illness that, in the opinion of the Investigator would compromise&#xD;
             subject safety or interfere with the evaluation of the safety of the study drug.&#xD;
&#xD;
          6. Subjects with documented cases of human immunodeficiency virus (HIV), or hepatitis B&#xD;
             or C.&#xD;
&#xD;
          7. Concurrent treatment with warfarin (Coumadin).&#xD;
&#xD;
          8. Known allergy to study drug or its excipients (PEG 200, PEG 400, Soy lecithin, Vitamin&#xD;
             E TPGS, and Propylene glycol) or severe allergy to other sulfonamides.&#xD;
&#xD;
          9. Gastrointestinal condition which could interfere with the swallowing or absorption of&#xD;
             study medication.&#xD;
&#xD;
         10. Refractory nausea and vomiting, chronic gastrointestinal diseases, gastrointestinal&#xD;
             bleeding, ulceration, or perforation within 12 weeks prior to the first administration&#xD;
             of SLC-0111 or significant bowel resection that would preclude adequate absorption.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alberta Health Services - Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Cancer Agency</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>May 13, 2016</last_update_submitted>
  <last_update_submitted_qc>May 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 17, 2016</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>Neoplasms</mesh_term>
  </condition_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/NCT02215850
org study id: OZM-055/SLC0111-14-C01
nct id: NCT02215850
lead sponsor: 
collaborator: 
has dmc: No
SLC-0111 is a selective, small molecule, inhibitor of carbonic anhydrase (CA) IX and is in
      development for the treatment of solid tumours over-expressing CA IX. CAIX, a transmembrane
      metalloenzyme, is overexpressed on extracellular surfaces of hypoxic tumour cells but its
      expression is highly restricted in normal tissue. CAIX is a functional regulator of processes
      critical for tumour growth and metastasis, including pH regulation, survival, migration and
      invasion.

      This prospective single arm study will evaluate the safety of SLC-0111 given once daily in 28
      day cycles in subjects with advanced solid tumours. The intent of this research study is to
      find our more information such as: the highest dose of SLC-0111 that can be given safely, the
      side effect it may cause, to examine how the body affects the study drug concentration in the
      blood (pharmacokinetics or PK), and to gain some information on its effectiveness in treating
      cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events
time frame: 1 year. Subjects will continue to receive SLC-0111 for multiple cycles of 28 days if they are receiving benefit from therapy.
description: To evaluate the safety and tolerability of SLC-0111, administered once daily, in subjects with advanced solid tumours.
measure: Area under the plasma concentration versus time curve (AUC) of SLC-0111
time frame: 1 year.
description: Changes in AUC over time in subjects taking SLC-0111 once daily.
arm group label: SLC-0111
arm group type: Experimental
intervention type: Drug
intervention name: SLC-0111
arm group label: SLC-0111
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Neoplasms