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Completed

NCT Number: NCT04467346

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

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.

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Key information

Conditions

Therapeutic Equivalency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Service de neuro-oncologie - Hospices Civils de Lyon, Bron, Rhône, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ped-TMZ

Drug

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 names: Temozolomide Oral Suspension

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Orphelia Pharma

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2020
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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