NCT04065087WithdrawnPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Genexine, Inc.
- Locations
- 1
- Primary Endpoint
- lymphocyte count
Study Overview
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 regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy (CCRT)
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 randomized, placebo controlled study and GX-I7 or Placebo will be administered in combination with adjuvant temozolomide treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Gliomatosis cerebri
- •Isocitrate dehydrogenase 1 & 2 mutation
- •Pregnant or breast feeding women
Outcomes
Primary Outcomes
lymphocyte count
Time Frame: 12 weeks
Change in absolute lymphocyte count
Secondary Outcomes
- Overall survival(36 months)
- Progression free survival(24 months)
Investigators
Study Sites (1)
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