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

Phase 2 Completed 81 enrolled Yong-Kil Hong Ajou University School of Medicine · collab Asan Medical Center · collab Chonnam National University Hospital · collab Incheon St.Mary's Hospital · collab Konkuk University Hospital · collab National Cancer Center, Korea · collab Saint Vincent's Hospital, Korea · collab Samsung Medical Center · collab Seoul National University Bundang Hospital · collab Seoul National University Hospital · collab Seoul St. Mary's Hospital · collab Severance Hospital · collab

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start: 2016-11-21
Primary completion: 2020-12-31
Completion: 2020-12-31

Outcome

Missed primary endpoint

paper Although the control group showed a longer median PFS, the difference between the two groups was not statistically significant (2.66 versus 2.3 months, p = 0.679). PMID 37278858 ↗

Publications

Yoon WS, Chang JH, Kim JH, Kim YJ, Jung TY, Yoo H, Kim SH, Ko YC, Nam DH, Kim TM, Kim SH, Park SH, Lee YS, Yim HW, Hong YK, Yang SH. Efficacy and safety of metformin plus low-dose temozolomide in patients with recurrent or refractory glioblastoma: a randomized, prospective, multicenter, double-blind, controlled, phase 2 trial (KNOG-1501 study). Discov Oncol. 2023 Jun 6;14(1):90. doi: 10.1007/s12672-023-00678-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	2000 mg	—
Background	Temozolomide	Small molecule	50 mg/m2	—