<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/NCT04467346</url>
  </required_header>
  <id_info>
    <org_study_id>ORP-TMZ-I-a</org_study_id>
    <nct_id>NCT04467346</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules</brief_title>
  <official_title>Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orphelia Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orphelia Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary objective:&#xD;
&#xD;
      • Evaluate bioequivalence between Temozolomide Oral Suspension and Temodal® capsules for oral&#xD;
      administration.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  Define the pharmacokinetic parameters of Temozolomide Oral Suspension.&#xD;
&#xD;
        -  Assess the buccal safety of Temozolomide Oral Suspension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is an open label, randomized, crossover, 2-period study in 30 male/female patients&#xD;
      with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of&#xD;
      Temozolomide Oral Suspension (Ped-TMZ) or Temodal®, as single oral administration in 2&#xD;
      different study periods depending on the randomization, with no wash out period between&#xD;
      administrations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2020</start_date>
  <completion_date type="Actual">December 17, 2021</completion_date>
  <primary_completion_date type="Actual">December 17, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>The study is an open label, randomized, crossover, 2-period study in 30 male/female patients with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of Temozolomide Oral Suspension (Ped-TMZ) or Temodal®, as single oral administration in 2 different study periods depending on the randomization, with no wash out period between administrations.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary pharmacokinetic parameter: Cmax</measure>
    <time_frame>Day 1 or Day 2</time_frame>
    <description>The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary pharmacokinetic parameter: AUC0-t</measure>
    <time_frame>Day 1 or Day 2</time_frame>
    <description>The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameter: AUC0-inf</measure>
    <time_frame>Day 1 or Day 2</time_frame>
    <description>The AUC0-inf pharmacokinetic parameter will be determined from temozolomide plasma concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameter: tmax</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>The tmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameter: λ</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>The λ pharmacokinetic parameter will be determined from temozolomide plasma concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameter: t1/2</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>The t1/2 pharmacokinetic parameters will be determined from temozolomide plasma concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameter: residual area</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>The residual area of temozolomide will be determined from temozolomide plasma concentrations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Therapeutic Equivalency</condition>
  <arm_group>
    <arm_group_label>Ped-TMZ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. Ped-TMZ will be administered using the provided dosing oral syringes and followed by a glass of 240 ml of water (for mouth rinsing) in sitting position and under fasting condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Temodal capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. The administration will take place around 8:00 a.m. followed with 240 mL of tap water, in sitting position and under fasting condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ped-TMZ</intervention_name>
    <description>Ped-TMZ will be administered using the provided dosing oral syringes and followed by a glass of 240 ml of water (for mouth rinsing) in sitting position and under fasting condition for at least 8 hours before dosing</description>
    <arm_group_label>Ped-TMZ</arm_group_label>
    <arm_group_label>Temodal capsule</arm_group_label>
    <other_name>Temozolomide Oral Suspension</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly diagnosed glioblastoma multiforme treated with temozolomide&#xD;
             (200mg/m2) as monotherapy and patients with recurrent or progressive malignant glioma&#xD;
             treated with temozolomide as monotherapy (200mg/m2).&#xD;
&#xD;
          -  Male and female patients at least 18 of age.&#xD;
&#xD;
          -  Non-pregnant, non-breast feeding female.&#xD;
&#xD;
          -  Body mass index (weight/height²) in the range of 18.5 to 30 kg/m².&#xD;
&#xD;
          -  Having given a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-administration of sodium valproate&#xD;
&#xD;
          -  Patients with (naso)gastric tubes&#xD;
&#xD;
          -  Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose&#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>Caroline Lemarchand, PharmD</last_name>
    <role>Study Director</role>
    <affiliation>Orphelia Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de neuro-oncologie - Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <state>Rhône</state>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Timone (AP-HM)</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>March 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>February 21, 2022</last_update_submitted>
  <last_update_submitted_qc>February 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temozolomide</mesh_term>
  </intervention_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/NCT04467346
org study id: ORP-TMZ-I-a
nct id: NCT04467346
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary objective:

      • Evaluate bioequivalence between Temozolomide Oral Suspension and Temodal® capsules for oral
      administration.

      Secondary objectives:

        -  Define the pharmacokinetic parameters of Temozolomide Oral Suspension.

        -  Assess the buccal safety of Temozolomide Oral Suspension.
The study is an open label, randomized, crossover, 2-period study in 30 male/female patients
      with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of
      Temozolomide Oral Suspension (Ped-TMZ) or Temodal®, as single oral administration in 2
      different study periods depending on the randomization, with no wash out period between
      administrations.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The study is an open label, randomized, crossover, 2-period study in 30 male/female patients with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of Temozolomide Oral Suspension (Ped-TMZ) or Temodal®, as single oral administration in 2 different study periods depending on the randomization, with no wash out period between administrations.
primary purpose: Treatment
masking: None (Open Label)
measure: Primary pharmacokinetic parameter: Cmax
time frame: Day 1 or Day 2
description: The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
measure: Primary pharmacokinetic parameter: AUC0-t
time frame: Day 1 or Day 2
description: The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations
measure: Secondary pharmacokinetic parameter: AUC0-inf
time frame: Day 1 or Day 2
description: The AUC0-inf pharmacokinetic parameter will be determined from temozolomide plasma concentrations
measure: Secondary pharmacokinetic parameter: tmax
time frame: Day 1 and Day 2
description: The tmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
measure: Secondary pharmacokinetic parameter: λ
time frame: Day 1 and Day 2
description: The λ pharmacokinetic parameter will be determined from temozolomide plasma concentrations
measure: Secondary pharmacokinetic parameter: t1/2
time frame: Day 1 and Day 2
description: The t1/2 pharmacokinetic parameters will be determined from temozolomide plasma concentrations
measure: Secondary pharmacokinetic parameter: residual area
time frame: Day 1 and Day 2
description: The residual area of temozolomide will be determined from temozolomide plasma concentrations
arm group label: Ped-TMZ
arm group type: Experimental
description: Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. Ped-TMZ will be administered using the provided dosing oral syringes and followed by a glass of 240 ml of water (for mouth rinsing) in sitting position and under fasting condition.
arm group label: Temodal capsule
arm group type: Active Comparator
description: Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. The administration will take place around 8:00 a.m. followed with 240 mL of tap water, in sitting position and under fasting condition
intervention type: Drug
intervention name: Ped-TMZ
description: Ped-TMZ will be administered using the provided dosing oral syringes and followed by a glass of 240 ml of water (for mouth rinsing) in sitting position and under fasting condition for at least 8 hours before dosing
arm group label: Ped-TMZ
arm group label: Temodal capsule
other name: Temozolomide Oral Suspension
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Caroline Lemarchand, PharmD
role: Study Director
affiliation: Orphelia Pharma
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Temozolomide
sharing ipd: No