NCT03250299

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase I study investigated the side-effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly-diagnosed O6-methylguanine-DNA methyltransferase (MGMT) promoter unmethylated glioblastoma (GBM). 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, stopping them from dividing, or 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 GBM.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of microtubule-targeted agent BAL101553 (BAL101553) in combination with standard radiation in patients with newly diagnosed MGMT promoter unmethylated 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. OUTLINE: This was a dose escalation study of the microtubule-targeted agent BAL101553. Patients received BAL101553 orally (PO) once daily (QD) for 6 weeks, concurrent with standard radiation therapy (RT) 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. This treatment period was followed by a 4-week no-treatment period. The duration of study treatment was defined as these 6 weeks of treatment plus the 4 weeks of rest. The safety evaluation period was the 10 weeks from start of treatment After completion of study treatment, patients were followed up at 30 days, and then every 2 months for 2 years and then every 6 months thereafter.

Conditions

• Glioblastoma
• MGMT-Unmethylated Glioblastoma

Interventions

Type	Name	Description
DRUG	Microtubule-Targeted Agent BAL101553	Given PO
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

• Start date: 2017-12-15
• Primary completion: 2022-06-03
• Completion: 2022-08-24
• First posted: 2017-08-15
• Last updated: 2024-06-24
• Results posted: 2024-06-24

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study