Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03452930
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2018-02-16
Brief Title:
Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study to Investigate the Safety Pharmacokinetic Profile and the Efficacy of EDO-S101 a First-in-Class Alkylating HDACi Fusion Molecule in Patients With Newly Di-Agnosed MGMT-Promoter Unmethylated Glioblastoma
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of tinostamustine EDO-S101 given with or without radiation therapy in treating patients with newly diagnosed MGMT-unmethylated glioblastoma Tinostamustine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in patients with glioblastoma
Detailed Description:
PRIMARY OBJECTIVES
I To characterize the safety profile and determine the maximum tolerated dose MTD of tinostamustine EDO-S101 in the adjuvant phase of therapy for patients with newly diagnosed MGMT-promoter unmethylated glioblastoma GB post chemoradiation with temozolomide Stage 1 II To characterize the safety profile and determine the MTD of EDO-S101 when given as a single agent in the concomitant phase with radiation therapy RT in patients with newly diagnosed GB who are MGMT-promoter unmethylated Stage 2 III To confirm the MTD of EDO-S101 in the concomitant phase and adjuvant phase in an expanded population of newly diagnosed GB patients who are MGMT-promoter un-methylated Dose Expansion Group
SECONDARY OBJECTIVE
I To assess anti-tumor activity for patients with newly diagnosed GB who are MGMT-promoter unmethylated based on progression-free survival PFS overall survival OS and overall response rate ORR
EXPLORATORY OBJECTIVE
I Profiling tumor deoxyribonucleic acid DNA messenger ribonucleic acid mRNA microRNA and epigenetic profiling DNA methylation and evaluation of whole exome sequencing RNA sequencing microRNA sequencing and cell-free circulating tumor DNA ctDNA and correlate with outcome
OUTLINE This is a dose-escalation study of tinostamustine Patients are assigned to 1 of 2 stages
STAGE 1 Patients who have completed temozolomide TMZ and radiation therapy RT receive tinostamustine intravenously IV over 60 minutes on day 1 Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity
STAGE 2 Patients who have received no treatment other than surgery undergo RT 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity Patients also receive tinostamustine over 60 minutes IV on day 1 Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3 months
I To characterize the safety profile and determine the maximum tolerated dose MTD of tinostamustine EDO-S101 in the adjuvant phase of therapy for patients with newly diagnosed MGMT-promoter unmethylated glioblastoma GB post chemoradiation with temozolomide Stage 1 II To characterize the safety profile and determine the MTD of EDO-S101 when given as a single agent in the concomitant phase with radiation therapy RT in patients with newly diagnosed GB who are MGMT-promoter unmethylated Stage 2 III To confirm the MTD of EDO-S101 in the concomitant phase and adjuvant phase in an expanded population of newly diagnosed GB patients who are MGMT-promoter un-methylated Dose Expansion Group
SECONDARY OBJECTIVE
I To assess anti-tumor activity for patients with newly diagnosed GB who are MGMT-promoter unmethylated based on progression-free survival PFS overall survival OS and overall response rate ORR
EXPLORATORY OBJECTIVE
I Profiling tumor deoxyribonucleic acid DNA messenger ribonucleic acid mRNA microRNA and epigenetic profiling DNA methylation and evaluation of whole exome sequencing RNA sequencing microRNA sequencing and cell-free circulating tumor DNA ctDNA and correlate with outcome
OUTLINE This is a dose-escalation study of tinostamustine Patients are assigned to 1 of 2 stages
STAGE 1 Patients who have completed temozolomide TMZ and radiation therapy RT receive tinostamustine intravenously IV over 60 minutes on day 1 Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity
STAGE 2 Patients who have received no treatment other than surgery undergo RT 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity Patients also receive tinostamustine over 60 minutes IV on day 1 Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3 months
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 |
|---|---|---|---|
| NCI-2018-00872 | REGISTRY | None | None |
| 2017-0555 | OTHER | M D Anderson Cancer Center | None |