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Safety Study of the Combination of Tandutinib With Temozolomide and Bevacizumab After Radiation and Temozolomide in Patients With Newly Diagnosed With Glioblastoma Multiforme

Study Purpose

This is a safety study of tandutinib in combination with temozolomide and bevacizumab after people have received radiation therapy and temozolomide treatment. This study will determine the maximum safe dose of tandutinib when combined with temozolomide and bevacizumab and evaluate the safety of the combination treatment.

Recruitment Criteria

Accepts Healthy Volunteers

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

 Yes
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.

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

Inclusion Criteria:

  • - Diagnosis of glioblastoma multiforme.
  • - Received radiotherapy for glioblastoma multiforme.
  • - Patients who have not had previous treatments for glioblastoma multiforme (except for surgery, radiation and temozolomide therapy) - Females that are postmenopausal for at least 1 year prior to screening visit.
  • - 18 years of age and older.

Exclusion Criteria:

  • - Other brain cancers that are not diagnosed as glioblastoma multiforme.
  • - female patients who are lactating or are pregnant.
  • - HIV positive and/or any other active infection requiring therapy.
  • - Known hepatitis B or hepatitis C infection.
  • - Diagnosed or treated any other cancer within 2 years before the first dose.
  • - History of cardiovascular conditions and/or vascular disease.
- Allergic to any component of bevacizumab

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.

 NCT00904852
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.

 Phase 1
Lead Sponsor

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

 Millennium Pharmaceuticals, Inc.
Principal Investigator

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

 Sudha Parasuraman, MD
Principal Investigator Affiliation Millennium Pharmaceuticals, Inc.
Agency Class

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

 Industry
Overall Status Withdrawn
Countries
Conditions

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

 Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: Tandutinib, bevacizumab, and temozolomide

tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.

Interventions

Drug: - Tandutinib, bevacizumab, and temozolomide

All patients will have completed treatment with concurrent radiation therapy and temozolomide. Patients will be entered into different dosing groups of tandutinib. Patients will receive up to 6 cycles of treatment with oral temozolomide at 150 mg/m2 daily for the first 5 days of a 28 day cycle, oral tandutinib at escalating doses 250, 375, 500, or 625 mg twice daily on days 1 to 28, and intravenous bevacizumab at 10 mg/kg on days 1 and 15 of each cycle

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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