Therapeutic EquivalencyPhase 1NCT04467346
Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
A Phase 1 study testing Ped-TMZ in people with Therapeutic Equivalency, run by Orphelia Pharma at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- Ped-TMZ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Sep 2020to 17 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Co-administration of sodium valproate
- Patients with (naso)gastric tubes
- Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Bordeaux
Bordeaux, 33075
Service de neuro-oncologie - Hospices Civils de Lyon
Bron, Rhône, 69500
Hôpital de la Timone (AP-HM)
Marseille, 13005
About this study
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.
Read the 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.
- Conditions
- Therapeutic Equivalency
- Being tested
- Ped-TMZ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ped-TMZDrug
Also called Temozolomide Oral Suspension
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Ped-TMZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary pharmacokinetic parameter: Cmax
The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Measured: Day 1 or Day 2
Primary pharmacokinetic parameter: AUC0-t
The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Measured: Day 1 or Day 2
Secondary outcomes (5)
Secondary pharmacokinetic parameter: AUC0-inf
The AUC0-inf pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Measured: Day 1 or Day 2
Secondary pharmacokinetic parameter: tmax
The tmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Measured: Day 1 and Day 2
Secondary pharmacokinetic parameter: λ
The λ pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Measured: Day 1 and Day 2
Secondary pharmacokinetic parameter: t1/2
The t1/2 pharmacokinetic parameters will be determined from temozolomide plasma concentrations
Measured: Day 1 and Day 2
Secondary pharmacokinetic parameter: residual area
The residual area of temozolomide will be determined from temozolomide plasma concentrations
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start25 Sep 2020
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic EquivalencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orphelia Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline Lemarchand, PharmD, Study director, Orphelia Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467346
- Sponsor's protocol ID
- ORP-TMZ-I-a
- Status last verified
- Feb 2022
- First submitted
- 27 Mar 2020
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38140005
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
- ClinicalTrials.gov ID
- NCT04467346
- Acronym / sponsor ID
- ORP-TMZ-I-a
- Conditions
- Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Orphelia PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ped-TMZ | Experimental | Drug: Ped-TMZSingle 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. |
| Temodal capsule | Active comparator | Drug: Ped-TMZSingle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Co-administration of sodium valproate
- Patients with (naso)gastric tubes
- Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ped-TMZAlso: Temozolomide Oral SuspensionPed-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 | Drug | Ped-TMZ, Temodal capsule |
Primary outcome
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
5 secondary outcomes
Secondary pharmacokinetic parameter: AUC0-inf
Time frame: Day 1 or Day 2
Secondary pharmacokinetic parameter: tmax
Time frame: Day 1 and Day 2
Secondary pharmacokinetic parameter: λ
Time frame: Day 1 and Day 2
Secondary pharmacokinetic parameter: t1/2
Time frame: Day 1 and Day 2
Secondary pharmacokinetic parameter: residual area
Time frame: Day 1 and Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Derived from this study: PubMed 38140005Ducray 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Lemarchand, PharmD study director
Orphelia Pharma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ped-TMZ in people with Therapeutic Equivalency, run by Orphelia Pharma at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary pharmacokinetic parameter: Cmax (time frame: Day 1 or Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.