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Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma — METT  

Glioblastoma Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03243851
Study type Interventional
Source Seoul St. Mary's Hospital
Contact
Status Completed
Phase Phase 2
Start date November 21, 2016
Completion date December 31, 2020
View Details
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