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

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.

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00904852

Enrollment

Registered

2009-05-20

Start date

2009-06-30

Completion date

2010-06-30

Last updated

2009-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

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.

Interventions

DRUGTandutinib, 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements	Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026