Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tandutinib, bevacizumab, and temozolomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tandutinib, bevacizumab, and temozolomide
- description
- tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.
- interventionNames
- Drug: Tandutinib, bevacizumab, and temozolomide
Primary outcomes (1)
- measure
- Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements
- timeFrame
- Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available