Back to resultsSafety Study of the Combination of Tandutinib With Temozolomide and Bevacizumab After Radiation and Temozolomide in Patients With Newly Diagnosed With Glioblastoma Multiforme
Primary Purpose
Glioblastoma Multiforme
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tandutinib, bevacizumab, and temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tandutinib, bevacizumab, and temozolomide
Arm Description
tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.
Outcomes
Primary Outcome Measures
Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT00904852
First Posted
May 19, 2009
Last Updated
May 19, 2009
Sponsor
Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00904852
Brief Title
Safety Study of the Combination of Tandutinib With Temozolomide and Bevacizumab After Radiation and Temozolomide in Patients With Newly Diagnosed With Glioblastoma Multiforme
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Withdrawn
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Millennium Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tandutinib, bevacizumab, and temozolomide
Arm Type
Experimental
Arm Description
tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.
Intervention Type
Drug
Intervention Name(s)
Tandutinib, bevacizumab, and temozolomide
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements
Time Frame
Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudha Parasuraman, MD
Organizational Affiliation
Millennium Pharmaceuticals, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety Study of the Combination of Tandutinib With Temozolomide and Bevacizumab After Radiation and Temozolomide in Patients With Newly Diagnosed With Glioblastoma Multiforme
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