A Phase 1, Multicenter, Open-Label, Dose Escalation Study of Tandutinib (Formerly MLN518) in Combination With Temozolomide and Bevacizumab Following Concurrent Radiation Therapy and Temozolomide in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme.
18 Years
N/A
Both
Glioblastoma Multiforme
Trial Information
A Phase 1, Multicenter, Open-Label, Dose Escalation Study of Tandutinib (Formerly MLN518) in Combination With Temozolomide and Bevacizumab Following Concurrent Radiation Therapy and Temozolomide in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements
Outcome Time Frame:
Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15
Safety Issue:
Yes
Principal Investigator
Sudha Parasuraman, MD
Investigator Role:
Study Director
Investigator Affiliation:
Millennium Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
C03003
NCT ID:
NCT00904852
Start Date:
June 2009
Completion Date:
June 2010
Related Keywords:
- Glioblastoma Multiforme
- Glioblastoma
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