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Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma

Newly Diagnosed Glioblastoma Clinical Trial

Official title:
A Phase 1/2, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Anti-tumor Activity of GX-I7 Plus Adjuvant Temozolomide Combination Regimen in Patients With Newly Diagnosed With Glioblastoma

Clinical Trial Summary

This is a phase 1/2, randomized, placebo-controlled study to evaluate safety, tolerability, anti-tumor activity and impact on absolute lymphocyte count of GX-I7 plus adjuvant temozolomide combination regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy (CCRT)

Clinical Trial Description

In dose escalation stage (Phase 1 part), low/intermediate/high dose of GX-I7 will be administered in combination with adjuvant temozolomide to find recommended phase 2 dose. Phase 2 part will be randomized, placebo controlled study and GX-I7 or Placebo will be administered in combination with adjuvant temozolomide treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04065087
Study type Interventional
Source Genexine, Inc.
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date August 22, 2019
Completion date August 27, 2022
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