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Trial record 4 of 403 for:    temodal

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467346
Recruitment Status : Completed
First Posted : July 13, 2020
Last Update Posted : February 23, 2022
Sponsor:
Information provided by (Responsible Party):
Orphelia Pharma

Tracking Information
First Submitted Date  ICMJE March 27, 2020
First Posted Date  ICMJE July 13, 2020
Last Update Posted Date February 23, 2022
Actual Study Start Date  ICMJE September 25, 2020
Actual Primary Completion Date December 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • Primary pharmacokinetic parameter: Cmax [ Time Frame: Day 1 or Day 2 ]
    The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
  • Primary pharmacokinetic parameter: AUC0-t [ Time Frame: Day 1 or Day 2 ]
    The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • Secondary pharmacokinetic parameter: AUC0-inf [ Time Frame: Day 1 or Day 2 ]
    The AUC0-inf pharmacokinetic parameter will be determined from temozolomide plasma concentrations
  • Secondary pharmacokinetic parameter: tmax [ Time Frame: Day 1 and Day 2 ]
    The tmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
  • Secondary pharmacokinetic parameter: λ [ Time Frame: Day 1 and Day 2 ]
    The λ pharmacokinetic parameter will be determined from temozolomide plasma concentrations
  • Secondary pharmacokinetic parameter: t1/2 [ Time Frame: Day 1 and Day 2 ]
    The t1/2 pharmacokinetic parameters will be determined from temozolomide plasma concentrations
  • Secondary pharmacokinetic parameter: residual area [ Time Frame: Day 1 and Day 2 ]
    The residual area of temozolomide will be determined from temozolomide plasma concentrations
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
Official Title  ICMJE Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Therapeutic Equivalency
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ped-TMZ
  • 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
    Intervention: Drug: Ped-TMZ
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2022)
36
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2020)
30
Actual Study Completion Date  ICMJE December 17, 2021
Actual Primary Completion Date December 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04467346
Other Study ID Numbers  ICMJE ORP-TMZ-I-a
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Orphelia Pharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Orphelia Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Caroline Lemarchand, PharmD Orphelia Pharma
PRS Account Orphelia Pharma
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP