Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05432375
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2022-06-09
Brief Title:
Study of Tinostamustine for Adjuvant Treatment of Glioblastoma
Sponsor:
Mundipharma Research Limited
Organization:
Mundipharma Research Limited
Study Overview
Official Title:
A Phase 1 Study to Investigate the Safety Pharmacokinetics and Efficacy of Tinostamustine a Novel Alkylating and Deacetylase Inhibiting Molecule as Adjuvant Treatment in Patients With Newly Diagnosed Unmethylated MGMT-promoter Glioblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
The study is designed as an open label multi-center Phase 1 study of single agent tinostamustine used as adjuvant treatment in patients with newly diagnosed GBM who are MGMT unmethylated and have completed concomitant treatment with temozolomide and radiation Treatment with adjuvant tinostamustine will start within 5 weeks of completion of concomitant temozolomide and radiation The study is designed to define the MTD by evaluating toxicities during dose escalation Tinostamustine will be administered on Day 1 of a 21-day treatment cycle
The total number of treatment cycles is 12 for patients who continue to benefit from treatment without disease progression or intolerable toxicity Patients will enter a 33 design with dose escalationde-escalation depending on safety from the last treated cohort
The total number of treatment cycles is 12 for patients who continue to benefit from treatment without disease progression or intolerable toxicity Patients will enter a 33 design with dose escalationde-escalation depending on safety from the last treated cohort
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None