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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02343081 |
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Date of registration:
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07/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bioequivalence Study of Temozolomide in Patients With Primary Tumors of the Central Nervous System
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Scientific title:
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A Randomized, Open Label, Two-way Crossover, Single Dose Bioequivalence Study Comparing Dralitem® Capsules to the Reference Drug Temodal® Capsules in Patients With Primary Tumors of the Central Nervous System Under Fasting Conditions |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02343081 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Argentina
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Contacts
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Name:
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Alejandro D Muggeri, Physician |
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Address:
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Telephone:
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Email:
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Affiliation:
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FLENI Instituto Clínico-Quirúrgico de Diagnóstico y Tratamiento |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female patients with primary malignant tumors of the central nervous system
(CNS) excluding subjects with primary CNS lymphoma.
2. Age> 21 years.
3. There should be a gap of two weeks between the last surgery and/or radiotherapy
procedure and the day of randomization. If the procedure were intrabdominal, the gap
should be of four weeks.
4. Patients with neutrophils> 1.5 x 109 / L and platelets> 100 x 109 / L.
5. Signed written informed consent for participation in the trial.
Exclusion Criteria:
1. Known hypersensitivity to Temozolomide or any other ingredient of the pharmaceutical
formulation.
2. Any situation (eg. vomiting) that may interfere with the absorption of the product
under study.
3. Chemotherapy or biological therapy within four weeks prior to administering the
products under study.
4. Patients who experience any symptoms of toxicity to prior antineoplastic therapies
upon administration of the products under study.
5. Participation in other clinical research studies during the 90 days before the start
of this study.
6. History of alcohol or drugs abuse.
7. History of severe allergic reactions to any type of antigen.
8. History of gastrointestinal surgery (except uncomplicated appendectomy, of at least
three months old).
9. Patients whose clinical status would affect the safety of the products under study or
interfere with the pharmacokinetic evaluation, at the discretion of the investigator.
10. Pregnant women or women planning to become pregnant during the study.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Brain Neoplasms, Malignant, Primary
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Intervention(s)
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Drug: Temozolomide
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Primary Outcome(s)
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AUC0-t
[Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4]
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Cmax
[Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4]
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AUC0-8
[Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4]
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Secondary Outcome(s)
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Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: Up to two weeks post last dose]
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Secondary ID(s)
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RFF -0208
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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