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Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)

Study Purpose

The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor <=1.5 cm by magnetic resonance imaging (MRI).
  • - Age >=18 years.
  • - Hemoglobin >=10 g/dL.
  • - White blood cell count >=1.5x10^9/L.
  • - Platelet count >=100x10^9/L.
  • - Blood urea <=1.5 x upper limit of normal values (ULN).
  • - Creatinine <=1.5 x ULN.
  • - Bilirubin <=1.5 x ULN.
  • - Aspartate aminotransferase <=3 x ULN.
  • - Alanine aminotransferase <=3 x ULN.
  • - Alkaline phosphatase <=2 x ULN.

Exclusion Criteria:

  • - Tumor-specific pretreatment.
  • - Contraindication against radiotherapy and/or chemotherapy.
  • - Malignomas other than basaliomas.
  • - Existing or planned pregnancy or lactation or inadequate contraception.
  • - Psychiatric disease.
  • - Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00704808
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Merck Sharp & Dohme LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Arms & Interventions

Arms

: Patients

Patients with newly diagnosed and operated glioblastoma multiforme.

Interventions

Procedure: - Primary surgical treatment

Primary surgery for tumor resection.

Radiation: - Radiotherapy

Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.

Drug: - Temozolomide

Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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