<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/NCT02244606</url>
  </required_header>
  <id_info>
    <org_study_id>SCY-078-202</org_study_id>
    <nct_id>NCT02244606</nct_id>
  </id_info>
  <brief_title>Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis</brief_title>
  <official_title>Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scynexis, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scynexis, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral&#xD;
      SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the&#xD;
      treatment of invasive candidiasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are&#xD;
      eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or&#xD;
      standard-of-care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements</measure>
    <time_frame>from time of informed consent through 6-weeks after last study drug</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose of SCY-078 that achieves the target exposure (AUC)</measure>
    <time_frame>during randomized study drug (administered for a maximum of 23 days)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global response</measure>
    <time_frame>end of all antifungal therapy (administered for a maximum of 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response</measure>
    <time_frame>end of all antifungal therapy (administered for a maximum of 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiological response</measure>
    <time_frame>end of all antifungal therapy (administered for a maximum of 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse</measure>
    <time_frame>2-weeks and 6-weeks after the end of all antifungal therapy</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Mycoses</condition>
  <condition>Candidiasis, Invasive</condition>
  <condition>Candidemia</condition>
  <arm_group>
    <arm_group_label>SCY-078 500 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SCY-078 750 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard-of-care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SCY-078</intervention_name>
    <arm_group_label>SCY-078 500 mg</arm_group_label>
    <arm_group_label>SCY-078 750 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluconazole</intervention_name>
    <arm_group_label>Standard-of-care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Micafungin</intervention_name>
    <arm_group_label>Standard-of-care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of invasive candidiasis defined as a positive culture of blood or from&#xD;
             another normally sterile site for Candida.&#xD;
&#xD;
          -  Not of reproductive potential or if of reproductive potential, agrees to remain&#xD;
             abstinent or use 2 methods of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated&#xD;
             candidiasis or evidence of endophthalmitis.&#xD;
&#xD;
          -  Patient has failed treatment with an echinocandin for this episode of invasive&#xD;
             candidiasis.&#xD;
&#xD;
          -  Infection limited to the oropharynx, esophagus, urogenital system, or skin, or&#xD;
             sputum/bronchoalveolar lavage culture.&#xD;
&#xD;
          -  Participation in a clinical study with other investigational drug(s) within 30 days&#xD;
             prior to study entry or during this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Angulo, MD</last_name>
    <role>Study Director</role>
    <affiliation>Scynexis, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Regents University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercury Street Medical Group</name>
      <address>
        <city>Butte</city>
        <state>Montana</state>
        <zip>59701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas VA Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkland Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Veterans Healthcare System</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospitals and Clinics</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Militar Central</name>
      <address>
        <city>San Salvador</city>
        <country>El Salvador</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Rosales</name>
      <address>
        <city>San Salvador</city>
        <country>El Salvador</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cologne</name>
      <address>
        <city>Cologne</city>
        <state>North Rhine Westphalia</state>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finca El Palomar</name>
      <address>
        <city>Guatemala</city>
        <zip>Zona 16</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Mario Catarino Rivas</name>
      <address>
        <city>San Pedro Sula</city>
        <state>Cortes</state>
        <country>Honduras</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula</name>
      <address>
        <city>San Pedro Sula</city>
        <state>Cortes</state>
        <country>Honduras</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>El Salvador</country>
    <country>Germany</country>
    <country>Guatemala</country>
    <country>Honduras</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <disposition_first_submitted>October 20, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>October 20, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 27, 2020</disposition_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Invasive Candidiasis</keyword>
  <keyword>Invasive Candida infections</keyword>
  <keyword>Candidemia</keyword>
  <keyword>SCY-078</keyword>
  <keyword>Micafungin</keyword>
  <keyword>Fluconazole</keyword>
  <keyword>Echinocandin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Candidiasis</mesh_term>
    <mesh_term>Candidemia</mesh_term>
    <mesh_term>Candidiasis, Invasive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluconazole</mesh_term>
    <mesh_term>Micafungin</mesh_term>
    <mesh_term>Ibrexafungerp</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>February 8, 2023</submitted>
    <returned>March 7, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02244606
org study id: SCY-078-202
nct id: NCT02244606
lead sponsor: 
has dmc: No
The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral
      SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the
      treatment of invasive candidiasis.
Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are
      eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or
      standard-of-care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements
time frame: from time of informed consent through 6-weeks after last study drug
measure: Dose of SCY-078 that achieves the target exposure (AUC)
time frame: during randomized study drug (administered for a maximum of 23 days)
measure: Global response
time frame: end of all antifungal therapy (administered for a maximum of 28 days)
measure: Clinical response
time frame: end of all antifungal therapy (administered for a maximum of 28 days)
measure: Microbiological response
time frame: end of all antifungal therapy (administered for a maximum of 28 days)
measure: Relapse
time frame: 2-weeks and 6-weeks after the end of all antifungal therapy
arm group label: SCY-078 500 mg
arm group type: Experimental
description: A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
arm group label: SCY-078 750 mg
arm group type: Experimental
description: A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
arm group label: Standard-of-care
arm group type: Active Comparator
description: Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
intervention type: Drug
intervention name: SCY-078
arm group label: SCY-078 500 mg
arm group label: SCY-078 750 mg
intervention type: Drug
intervention name: Fluconazole
arm group label: Standard-of-care
intervention type: Drug
intervention name: Micafungin
arm group label: Standard-of-care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: David Angulo, MD
role: Study Director
affiliation: Scynexis, Inc.
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country: El Salvador
country: Germany
country: Guatemala
country: Honduras
country: United States
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Candidiasis
mesh term: Candidemia
mesh term: Candidiasis, Invasive
mesh term: Fluconazole
mesh term: Micafungin
mesh term: Ibrexafungerp
submitted: February 8, 2023
returned: March 7, 2023