Status:
COMPLETED
Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
Lead Sponsor:
Orphelia Pharma
Conditions:
Therapeutic Equivalency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary objective: • Evaluate bioequivalence between Temozolomide Oral Suspension and Temodal® capsules for oral administration. Secondary objectives: * Define the pharmacokinetic parameters of Tem...
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 O...
Eligibility Criteria
Inclusion
- 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
- Co-administration of sodium valproate
- Patients with (naso)gastric tubes
- Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04467346
Start Date
September 25 2020
End Date
December 17 2021
Last Update
February 23 2022
Active Locations (3)
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1
Service de neuro-oncologie - Hospices Civils de Lyon
Bron, Rhône, France, 69500
2
CHU de Bordeaux
Bordeaux, France, 33075
3
Hôpital de la Timone (AP-HM)
Marseille, France, 13005