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

NCT03243851 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2021-09-09

No results posted yet for this study

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

Conditions

Interventions

DRUG

Temozolomide+Metformin

Low dose temozolomide+metformin for 24 weeks

DRUG

Temozolomide+Placebo

Low dose temozolomide+placebo for 24 weeks

Sponsors & Collaborators

  • Saint Vincent's Hospital, Korea

    collaborator OTHER

  • Incheon St.Mary's Hospital

    collaborator OTHER

  • National Cancer Center, Korea

    collaborator OTHER_GOV

  • Konkuk University Hospital

    collaborator OTHER

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Ajou University School of Medicine

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Chonnam National University Hospital

    collaborator OTHER

  • Seoul St. Mary's Hospital

    collaborator OTHER

  • Yong-Kil Hong

    lead OTHER

Principal Investigators

  • Yong-Kil Hong, MD.,PhD. · Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243851 on ClinicalTrials.gov