Phase 4
N=16
Bioequivalence Study of Temozolomide in Patients With Primary Tumors of the Central Nervous System
Brain Neoplasms, Malignant, Primary
Bottom Line
View on ClinicalTrials.gov: NCT02343081 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Cmax — 11.108; 10.575 mcg/mL — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Temozolomide (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Monte Verde SA
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
11.108; 10.575 | <0.05 sig |
| PRIMARY AUC0-t |
30.796; 31.104 | <0.05 sig |
| PRIMARY AUC0-∞ |
31.817; 32.290 | <0.05 sig |
| SECONDARY Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
— | — |
Summary
The purpose of this crossover, single-dose, bioequivalence study is to compare the rate and extent of absorption of Temozolomide after the administration of the study product (Dralitem®, Monte Verde S.A.) and the reference product (Temodal®, Schering Plough) in primary Central Nervous System patients.
Eligibility Criteria
Inclusion Criteria
- Male or female patients with primary malignant tumors of the central nervous system (CNS) excluding subjects with primary CNS lymphoma.
- Age> 21 years.
- 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.
- Patients with neutrophils> 1.5 x 109 / L and platelets> 100 x 109 / L.
- Signed written informed consent for participation in the trial.
Exclusion Criteria
- Known hypersensitivity to Temozolomide or any other ingredient of the pharmaceutical formulation.
- Any situation (eg. vomiting) that may interfere with the absorption of the product under study.
- Chemotherapy or biological therapy within four weeks prior to administering the products under study.
- Patients who experience any symptoms of toxicity to prior antineoplastic therapies upon administration of the products under study.
- Participation in other clinical research studies during the 90 days before the start of this study.
- History of alcohol or drugs abuse.
- History of severe allergic reactions to any type of antigen.
- History of gastrointestinal surgery (except uncomplicated appendectomy, of at least three months old).
- 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.
- Pregnant women or women planning to become pregnant during the study.
Data sourced from ClinicalTrials.gov (NCT02343081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.