Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03250299
Status:
TERMINATED
Last Update Posted:
2024-06-24
First Post:
2017-07-28
Brief Title:
Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the National Cancer Institutes NCI-mandated termination of the Adult Brain Tumor Consortium which was conducting the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDI-CS-004 | OTHER | None | None |
| IRB00131687 | OTHER | JHM IRB | None |