Bioequivalence Study of Temozolomide in Patients With Primary Tumors of the Central Nervous System

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Monte Verde SA
• Collaborators: Bioanalytical Unit, Laboratorio Raffo S.A., BA, Argentina.; FLENI Instituto de Rehabilitación y Educación Terapéutica, BA, Argentina.; FLENI Multi-Specialty Research Center, BA, Argentina.
• Treatments: Dacarbazine; Temozolomide

Criteria

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.