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Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules

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ClinicalTrials.gov Identifier: NCT04467346
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Orphelia Pharma

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Therapeutic Equivalency Drug: Ped-TMZ Phase 1

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ped-TMZ
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.
 Drug: Ped-TMZ
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
Other Name: Temozolomide Oral Suspension
Active Comparator: Temodal capsule
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
 Drug: Ped-TMZ
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
Other Name: Temozolomide Oral Suspension


Outcome Measures
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Primary Outcome Measures :
  1. Primary pharmacokinetic parameter: Cmax [ Time Frame: Day 1 or Day 2 ]
    The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations

  2. Primary pharmacokinetic parameter: AUC0-t [ Time Frame: Day 1 or Day 2 ]
    The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations


Secondary Outcome Measures :
  1. Secondary pharmacokinetic parameter: AUC0-inf [ Time Frame: Day 1 or Day 2 ]
    The AUC0-inf pharmacokinetic parameter will be determined from temozolomide plasma concentrations

  2. Secondary pharmacokinetic parameter: tmax [ Time Frame: Day 1 and Day 2 ]
    The tmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations

  3. Secondary pharmacokinetic parameter: λ [ Time Frame: Day 1 and Day 2 ]
    The λ pharmacokinetic parameter will be determined from temozolomide plasma concentrations

  4. Secondary pharmacokinetic parameter: t1/2 [ Time Frame: Day 1 and Day 2 ]
    The t1/2 pharmacokinetic parameters will be determined from temozolomide plasma concentrations

  5. Secondary pharmacokinetic parameter: residual area [ Time Frame: Day 1 and Day 2 ]
    The residual area of temozolomide will be determined from temozolomide plasma concentrations


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed glioblastoma multiforme treated with temozolomide (200mg/m2) as monotherapy and patients with recurrent or progressive malignant glioma treated with temozolomide as monotherapy (200mg/m2).
  • Male and female patients at least 18 of age.
  • Non-pregnant, non-breast feeding female.
  • Body mass index (weight/height²) in the range of 18.5 to 30 kg/m².
  • Having given a written informed consent

Exclusion Criteria:

  • Co-administration of sodium valproate
  • Patients with (naso)gastric tubes
  • Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467346


Contacts
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Contact: Caroline Lemarchand, PharmD +33142770818 ext +33142770818 caroline.lemarchand@orphelia-pharma.eu

Locations
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France
Service de neuro-oncologie - Hospices Civils de Lyon Recruiting
Bron, Rhône, France, 69500
Contact: François Ducray, Pr         
CHU de Bordeaux Recruiting
Bordeaux, France, 33075
Contact: Charlotte Bronnimann, MD         
Hôpital de la Timone (AP-HM) Recruiting
Marseille, France, 13005
Contact: Olivier Chinot, Pr         
Sponsors and Collaborators
Orphelia Pharma
Investigators
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Study Director: Caroline Lemarchand, PharmD Orphelia Pharma
More Information
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Responsible Party: Orphelia Pharma
ClinicalTrials.gov Identifier: NCT04467346    
Other Study ID Numbers: ORP-TMZ-I-a
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents