<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/NCT03241550</url>
  </required_header>
  <id_info>
    <org_study_id>9766-CL-0046</org_study_id>
    <nct_id>NCT03241550</nct_id>
  </id_info>
  <brief_title>A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients</brief_title>
  <official_title>A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Basilea Pharmaceutica International Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</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 purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of&#xD;
      multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in&#xD;
      pediatric patients. The PK data will be utilized to establish a pediatric population PK model&#xD;
      of isavuconazole, the active moiety of isavuconazonium sulfate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">July 5, 2019</completion_date>
  <primary_completion_date type="Actual">July 5, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK) of isavuconazole in plasma: Cmax at steady state</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Maximum concentration at steady state (Cmax) will be derived from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of isavuconazole in plasma: AUCtau</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Area under the concentration time curve from the time of dosing to the start of next dosing interval at multiple dose conditions (AUCtau) will be derived from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of isavuconazole in plasma: tmax</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Time of maximum concentration (tmax) will be derived from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of isavuconazole in plasma: Ctrough</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Concentration - trough level (Ctrough) will be derived from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of isavuconazole in plasma: CL</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Clearance (CL) will be model-derived.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of isavuconazole in plasma: Vss</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Volume of distribution at steady state (Vss) will be model-derived.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of isavuconazole in plasma: AUCss</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Area under the concentration-time curve at steady state (AUCss) will be model-derived.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of isavuconazole in plasma: t 1/2</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Half-life (t1/2) will be model-derived.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety assessed by nature, frequency and severity of Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to 58 days</time_frame>
    <description>A TEAE is defined as an Adverse Event (AE) observed after starting administration of the study drug through follow-up. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Number of patients with TEAE's will be summarized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with vital sign abnormalities and/or adverse events</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>An abnormality identified during a medical test (e.g. vital signs) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with laboratory value abnormalities and/or adverse events</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>An abnormality identified during a medical test (e.g. laboratory parameter) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety assessed by routine 12- lead electrocardiogram (ECG)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Standard 12-lead ECG recordings will be used for the purposes of safety assessment. A 12-lead, resting ECG is to be recorded. Patients should remain supine for at least 5 minutes prior to all ECGs being performed. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Hematological Malignancy</condition>
  <arm_group>
    <arm_group_label>isavuconazonium sulfate IV cohort 1: 1 to &lt; 6 years of age</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an intravenous (IV) loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>isavuconazonium sulfate IV cohort 2: 6 to &lt; 12 years of age</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>isavuconazonium sulfate IV cohort 3: 12 to &lt; 18 years of age</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>isavuconazonium sulfate oral cohort 4: 6 to &lt; 12 years of age</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>isavuconazonium sulfate oral cohort 5: 12 to &lt; 18 years of age</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>isavuconazonium sulfate - intravenous</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>isavuconazonium sulfate IV cohort 1: 1 to &lt; 6 years of age</arm_group_label>
    <arm_group_label>isavuconazonium sulfate IV cohort 2: 6 to &lt; 12 years of age</arm_group_label>
    <arm_group_label>isavuconazonium sulfate IV cohort 3: 12 to &lt; 18 years of age</arm_group_label>
    <other_name>Cresemba®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>isavuconazonium sulfate - oral</intervention_name>
    <description>Oral</description>
    <arm_group_label>isavuconazonium sulfate oral cohort 4: 6 to &lt; 12 years of age</arm_group_label>
    <arm_group_label>isavuconazonium sulfate oral cohort 5: 12 to &lt; 18 years of age</arm_group_label>
    <other_name>Cresemba®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has sufficient venous access to permit administration of study drug (for the&#xD;
             IV cohorts), collection of pharmacokinetic samples and monitoring of safety&#xD;
             laboratories.&#xD;
&#xD;
          -  Female subject must either:&#xD;
&#xD;
               -  Be of non-childbearing potential: Clearly premenarchal or documented surgically&#xD;
                  sterile&#xD;
&#xD;
               -  Or, if of childbearing potential: Agree not to try to become pregnant during the&#xD;
                  study and for 28 days after the final study drug administration; and have a&#xD;
                  negative urine or serum pregnancy test at screening; and, if heterosexually&#xD;
                  active, agree to consistently use 2 forms of highly effective birth control (at&#xD;
                  least one of which must be a barrier method) starting at screening and throughout&#xD;
                  the study and for 28 days after the final study drug administration.&#xD;
&#xD;
          -  Female subject who is of childbearing potential must agree not to breastfeed starting&#xD;
             at screening and throughout the study and for 28 days after the final study drug&#xD;
             administration.&#xD;
&#xD;
          -  Female subject who is of childbearing potential must not donate ova starting at&#xD;
             screening and throughout the study and for 28 days after the final study drug&#xD;
             administration.&#xD;
&#xD;
          -  Male subject who is of childbearing potential and their female spouse/partner who is&#xD;
             of childbearing potential must be using highly effective contraception consisting of 2&#xD;
             forms of birth control (at least one of which must be a barrier method) starting at&#xD;
             screening and continue throughout the study, and for 90 days after the final study&#xD;
             drug administration.&#xD;
&#xD;
          -  Male subject who is of childbearing potential must not donate sperm starting at&#xD;
             screening and throughout the study and, for 90 days after the final study drug&#xD;
             administration.&#xD;
&#xD;
          -  Subject and subject's parent(s) or legal guardian agree that the subject will not&#xD;
             participate in another interventional study while on treatment.&#xD;
&#xD;
          -  For oral cohorts: subject is able to swallow the oral capsule medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has familial short QT syndrome, is receiving medications that are known to&#xD;
             shorten the QT interval, or has a clinically significant abnormal electrocardiogram&#xD;
             (ECG).&#xD;
&#xD;
          -  Subject has evidence of hepatic dysfunction defined as:&#xD;
&#xD;
               -  Total bilirubin ≥ 3 times the upper limit of normal (ULN)&#xD;
&#xD;
               -  Alanine transaminase or aspartate transaminase ≥ 5 times the ULN&#xD;
&#xD;
               -  Known cirrhosis or chronic hepatic failure&#xD;
&#xD;
          -  Subject has used strong cytochrome P450 (CYP) 3A4 inhibitors or inducers such as&#xD;
             ketoconazole, rifampin/rifampicin, long acting barbiturates, carbamazepine and St.&#xD;
             John's wort in the 5 days prior to the first administration of study drug.&#xD;
&#xD;
          -  Subject has known history of allergy, hypersensitivity, or any serious reaction to any&#xD;
             of the azole class antifungals.&#xD;
&#xD;
          -  Subject has any condition which makes the subject unsuitable for study participation.&#xD;
&#xD;
          -  Subject is unlikely to survive 30 days.&#xD;
&#xD;
          -  Subject has received investigational therapy, with the exception of oncology drug&#xD;
             trials, within 28 days or 5 half-lives, whichever is longer, prior to screening.&#xD;
&#xD;
          -  For oral cohorts: The subject has gastrointestinal disease or has had a procedure that&#xD;
             is expected to interfere with the oral absorption or tolerance of the study drug&#xD;
             (e.g., functionally relevant gastrointestinal obstruction, mucositis/stomatitis, or&#xD;
             frequent vomiting).&#xD;
&#xD;
          -  Subject previously dosed with isavuconazonium sulfate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senior Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miller Children's Hospital</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHOC Children's Hospital of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nicklaus Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospitals and Clinics of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</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>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at TriStar Centennial Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</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>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>invasive fungal disease</keyword>
  <keyword>Cresemba®</keyword>
  <keyword>Hematological malignancy</keyword>
  <keyword>isavuconazonium sulfate</keyword>
  <keyword>ASP9766</keyword>
  <keyword>isavuconazole</keyword>
  <keyword>pediatric population</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isavuconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </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/NCT03241550
org study id: 9766-CL-0046
nct id: NCT03241550
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of
      multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in
      pediatric patients. The PK data will be utilized to establish a pediatric population PK model
      of isavuconazole, the active moiety of isavuconazonium sulfate.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetics (PK) of isavuconazole in plasma: Cmax at steady state
time frame: Up to 7 days
description: Maximum concentration at steady state (Cmax) will be derived from the PK plasma samples collected.
measure: PK of isavuconazole in plasma: AUCtau
time frame: Up to 7 days
description: Area under the concentration time curve from the time of dosing to the start of next dosing interval at multiple dose conditions (AUCtau) will be derived from the PK plasma samples collected.
measure: PK of isavuconazole in plasma: tmax
time frame: Up to 7 days
description: Time of maximum concentration (tmax) will be derived from the PK plasma samples collected.
measure: PK of isavuconazole in plasma: Ctrough
time frame: Up to 28 days
description: Concentration - trough level (Ctrough) will be derived from the PK plasma samples collected.
measure: PK of isavuconazole in plasma: CL
time frame: Up to 28 days
description: Clearance (CL) will be model-derived.
measure: PK of isavuconazole in plasma: Vss
time frame: Up to 28 days
description: Volume of distribution at steady state (Vss) will be model-derived.
measure: PK of isavuconazole in plasma: AUCss
time frame: Up to 28 days
description: Area under the concentration-time curve at steady state (AUCss) will be model-derived.
measure: PK of isavuconazole in plasma: t 1/2
time frame: Up to 28 days
description: Half-life (t1/2) will be model-derived.
measure: Safety assessed by nature, frequency and severity of Treatment Emergent Adverse Events (TEAEs)
time frame: Up to 58 days
description: A TEAE is defined as an Adverse Event (AE) observed after starting administration of the study drug through follow-up. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Number of patients with TEAE's will be summarized.
measure: Number of patients with vital sign abnormalities and/or adverse events
time frame: Up to 28 days
description: An abnormality identified during a medical test (e.g. vital signs) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.
measure: Number of patients with laboratory value abnormalities and/or adverse events
time frame: Up to 28 days
description: An abnormality identified during a medical test (e.g. laboratory parameter) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.
measure: Safety assessed by routine 12- lead electrocardiogram (ECG)
time frame: Up to 28 days
description: Standard 12-lead ECG recordings will be used for the purposes of safety assessment. A 12-lead, resting ECG is to be recorded. Patients should remain supine for at least 5 minutes prior to all ECGs being performed. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded.
arm group label: isavuconazonium sulfate IV cohort 1: 1 to < 6 years of age
arm group type: Experimental
description: Patients will receive an intravenous (IV) loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).
arm group label: isavuconazonium sulfate IV cohort 2: 6 to < 12 years of age
arm group type: Experimental
description: Patients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).
arm group label: isavuconazonium sulfate IV cohort 3: 12 to < 18 years of age
arm group type: Experimental
description: Patients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).
arm group label: isavuconazonium sulfate oral cohort 4: 6 to < 12 years of age
arm group type: Experimental
description: Patients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).
arm group label: isavuconazonium sulfate oral cohort 5: 12 to < 18 years of age
arm group type: Experimental
description: Patients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).
intervention type: Drug
intervention name: isavuconazonium sulfate - intravenous
description: IV infusion
arm group label: isavuconazonium sulfate IV cohort 1: 1 to < 6 years of age
arm group label: isavuconazonium sulfate IV cohort 2: 6 to < 12 years of age
arm group label: isavuconazonium sulfate IV cohort 3: 12 to < 18 years of age
other name: Cresemba®
intervention type: Drug
intervention name: isavuconazonium sulfate - oral
description: Oral
arm group label: isavuconazonium sulfate oral cohort 4: 6 to < 12 years of age
arm group label: isavuconazonium sulfate oral cohort 5: 12 to < 18 years of age
other name: Cresemba®
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
last name: Senior Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms
mesh term: Isavuconazole
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."