NCT02343081

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 2, 2015

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

January 7, 2015

Results QC Date

February 23, 2015

Last Update Submit

March 20, 2015

Conditions

Brain Neoplasms, Malignant, Primary

Keywords

brain neoplasmbioequivalencetemozolomide

Outcome Measures

Primary Outcomes (3)

  • Cmax

    Rate of absorption of Temozolomide (Cmax) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).

    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

  • AUC0-t

    Extent of absorption of Temozolomide from time (0) to the last quantifiable concentration (t) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough)

    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

  • AUC0-∞

    Extent of absorption of Temozolomide from time (0) to infinity (∞) will be measured after oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).

    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

Secondary Outcomes (1)

  • Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Up to two weeks post last dose

Other Outcomes (2)

  • Kel

    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

  • T1/2

    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

Study Arms (2)

Temodal

ACTIVE COMPARATOR

Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.

Drug: Temozolomide

Dralitem

EXPERIMENTAL

Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose

Drug: Temozolomide

Interventions

TemozolomideDRUG
Also known as: Temodal
Temodal

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

FLENI Instituto de Rehabilitación y Educación Terapéutica

Belén de Escobar, Buenos Aires, B1625XAS, Argentina

Location

FLENI Instituto Clínico-Quirúrgico de Diagnóstico y Tratamiento

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1428AQK, Argentina

Location

Related Publications (1)

  • Muggeri A, Vago M, Perez S, Rubio M, Gonzalez C, Magarinos C, Rosenberg M, Costa F, Perez-Lloret S. A Randomized, Open-Label, Two-Way Crossover, Single-Dose Bioequivalence Study of Temozolomide 200 mg/m2 (Dralitem(R) vs. Temodal(R) Capsules) in Patients with Primary Tumors of the Central Nervous System Under Fasting Conditions. Drugs R D. 2017 Sep;17(3):427-434. doi: 10.1007/s40268-017-0199-3.

    PMID: 28756607DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Alejandro Muggeri (Principal Investigator)
Organization
FLENI- mrc (FLENI Multi-specialty Research Center)
alemuggeri@hotmail.com.ar
54-11-5777 3200

Study Officials

  • Alejandro D Muggeri, Physician

    FLENI Instituto Clínico-Quirúrgico de Diagnóstico y Tratamiento

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 21, 2015

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 2, 2015

Results First Posted

April 2, 2015

Record last verified: 2015-03

Locations

AR(2)