Status:
WITHDRAWN
Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma
Lead Sponsor:
Genexine, Inc.
Conditions:
Newly Diagnosed Glioblastoma
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed 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 rand...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form (ICF)
- Age ≥ 19 years
- Gross total resection equal to or greater than 80% based on post-op MRI, compared to pre-op MRI (Patients requiring biopsy only is not eligible)
- Patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (CCRT) and adjuvant temozolomide chemotherapy with curative intent
- Karnofsky score ≥ 60
- Life expectancy \> 12 weeks
Exclusion
- Gliomatosis cerebri
- Isocitrate dehydrogenase 1 \& 2 mutation
- Pregnant or breast feeding women
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04065087
Start Date
August 22 2019
End Date
August 27 2022
Last Update
March 17 2022
Active Locations (1)
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1
St. Vincent Hospital
Suwon, South Korea