Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-04 @ 10:47 AM
Study NCT ID:
NCT03243851
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2017-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma
Sponsor:
Yong-Kil Hong
Organization:
Study Overview
Official Title:
Efficacy and Safety of Low Dose Temozolomide Plus Metformin as Combination Chemotherapy Compared With Low Dose Temozolomide Plus Placebo in Patient With Recurrent or Refractory Glioblastoma
Status:
COMPLETED
Status Verified Date:
2021-09
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:
METT
Brief Summary:
A phase 2 clinical trial for the efficacy and safety of low dose Temozolomide plus metformin as combination chemotherapy compared with low dose Temozolomide plus placebo in patient with recurrent or refractory Glioblastoma
Detailed Description:
Studies will investigate the efficacy and safety of low dose Temozolomide with Metformin or placebo for the patients with recurrent or refractory Glioblastoma.
The dosage of the Metformin will follow the domestically permitted dose to minimize side effects.
The patients will be allocated randomly to arm 1(experimental) and arm 2(placebo controlled) and administered the investigational products for up to 6 cycle. Each cycle consists of 4 weeks.
After 6 cycle(24 weeks), the patients will be checked progression and survival every 24 weeks up to 96 weeks.
The dosage of the Metformin will follow the domestically permitted dose to minimize side effects.
The patients will be allocated randomly to arm 1(experimental) and arm 2(placebo controlled) and administered the investigational products for up to 6 cycle. Each cycle consists of 4 weeks.
After 6 cycle(24 weeks), the patients will be checked progression and survival every 24 weeks up to 96 weeks.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: