Clinical trial NCT04467346: Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
Official title: Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Therapeutic Equivalency
Lead sponsor: Orphelia Pharma
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Primary pharmacokinetic parameter: Cmax
timeFrame: Day 1 or Day 2
measure: Primary pharmacokinetic parameter: AUC0-t
timeFrame: Day 1 or Day 2
Secondary outcomes:
measure: Secondary pharmacokinetic parameter: AUC0-inf
timeFrame: Day 1 or Day 2
measure: Secondary pharmacokinetic parameter: tmax
timeFrame: Day 1 and Day 2
measure: Secondary pharmacokinetic parameter: λ
timeFrame: Day 1 and Day 2
measure: Secondary pharmacokinetic parameter: t1/2
timeFrame: Day 1 and Day 2
measure: Secondary pharmacokinetic parameter: residual area
timeFrame: Day 1 and Day 2
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de neuro-oncologie - Hospices Civils de Lyon
state: Rhône
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Marseille
country: France
facility: Hôpital de la Timone (AP-HM)
Study officials:
affiliation: Orphelia Pharma
name: Caroline Lemarchand, PharmD
role: STUDY_DIRECTOR
References: