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Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Glioblastoma Clinical Trial

Official title:
Phase I Study to Determine the Safety and Tolerability of the Oral Microtubule Destabilizer BAL101553 in Combination With Standard Radiation in Patients With MGMT Promoter Unmethylated Newly Diagnosed Glioblastoma

Clinical Trial Summary

This phase I trial studies the side effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted agent BAL101553 and radiation therapy may work better in treating patients with glioblastoma.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of microtubule-targeted agent BAL101553 (BAL101553) in combination with standard radiation in patients with newly diagnosed MGMT promoter unmethylated glioblastoma (GBM). SECONDARY OBJECTIVES: I. To estimate safety and tolerability of the combination of BAL101553 in combination with standard radiation in patients with newly diagnosed MGMT promoter unmethylated GBM. II. To determine overall and progression-free survival. III. To assess the pharmacokinetics of BAL101553 and BAL27862. IV. To explore expression of biomarkers, including BubR1, stathmin and EB1 at baseline (exploratory biomarkers). OUTLINE: This is a dose escalation study of the microtubule-targeted agent BAL101553. Patients receive microtubule-targeted agent BAL101553 orally (PO) once daily (QD) on days 1-42 and undergo concomitant standard radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 2 months for 2 years and then every 6 months thereafter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03250299
Study type Interventional
Source Basilea Pharmaceutica
Contact
Status Terminated
Phase Phase 1
Start date June 7, 2017
Completion date August 24, 2022
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