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

NCT04467346 | Completed Phase 1

• 1 other identifier: ORP-TMZ-I-a
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (2)

• Primary pharmacokinetic parameter: Cmax

  The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations

  Day 1 or Day 2

• Primary pharmacokinetic parameter: AUC0-t

  The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations

  Day 1 or Day 2

Secondary Outcomes (5)

• Secondary pharmacokinetic parameter: AUC0-inf

  Day 1 or Day 2

• Secondary pharmacokinetic parameter: tmax

  Day 1 and Day 2

• Secondary pharmacokinetic parameter: λ

  Day 1 and Day 2

• Secondary pharmacokinetic parameter: t1/2

  Day 1 and Day 2

• Secondary pharmacokinetic parameter: residual area

  Day 1 and Day 2

Study Arms (2)

Ped-TMZ

EXPERIMENTAL

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

Temodal capsule

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Temozolomide Oral Suspension

Ped-TMZ; Temodal capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Co-administration of sodium valproate
• Patients with (naso)gastric tubes
• Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose

Sponsors & Collaborators

• Orphelia Pharma: lead

Study Sites (3)

Service de neuro-oncologie - Hospices Civils de Lyon

Bron, Rhône, 69500, France

Location

CHU de Bordeaux

Bordeaux, 33075, France

Location

Hôpital de la Timone (AP-HM)

Marseille, 13005, France

Location

Related Publications (1)

• Ducray F, Ramirez C, Robert M, Fontanilles M, Bronnimann C, Chinot O, Estrade F, Durando X, Cartalat S, Bastid J, Bienayme H, Lemarchand C. A Multicenter Randomized Bioequivalence Study of a Novel Ready-to-Use Temozolomide Oral Suspension vs. Temozolomide Capsules. Pharmaceutics. 2023 Nov 24;15(12):2664. doi: 10.3390/pharmaceutics15122664.

  PMID: 38140005 DERIVED

Study Officials

• Caroline Lemarchand, PharmD

  Orphelia Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 27, 2020
• First Posted: July 13, 2020
• Study Start: September 25, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)