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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04065087
• Other study ID #: GX-I7-CA-007
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: August 22, 2019
• Est. completion date: August 27, 2022

Study information

• Verified date: March 2022
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Signed Informed Consent Form (ICF)

2. Age = 19 years

3. 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)

4. Patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (CCRT) and adjuvant temozolomide chemotherapy with curative intent

5. Karnofsky score = 60

6. Life expectancy > 12 weeks

Exclusion Criteria:

1. Gliomatosis cerebri

2. Isocitrate dehydrogenase 1 & 2 mutation

3. Pregnant or breast feeding women

Related Conditions & MeSH terms

• Glioblastoma
• Newly Diagnosed Glioblastoma

Intervention

Biological:
• GX-I7
Investigational drug

Other:
• Placebo
Placebo drug

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent Hospital	Suwon-si

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lymphocyte count	Change in absolute lymphocyte count	12 weeks
Secondary	Overall survival	Median overall survival	36 months
Secondary	Progression free survival	Median progression free survival	24 months