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

Primary Purpose

Newly Diagnosed Glioblastoma

Status
Withdrawn
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GX-I7
Placebo
Sponsored by
Genexine, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed Glioblastoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Vincent Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GX-I7

Placebo

Arm Description

GX-I7 administered until Progression of Disease

Placebo administered until Progression of Disease

Outcomes

Primary Outcome Measures

lymphocyte count
Change in absolute lymphocyte count

Secondary Outcome Measures

Overall survival
Median overall survival
Progression free survival
Median progression free survival

Full Information

First Posted
July 25, 2019
Last Updated
March 2, 2022
Sponsor
Genexine, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04065087
Brief Title
Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Canceled by the sponsor
Study Start Date
August 22, 2019 (Anticipated)
Primary Completion Date
May 27, 2022 (Anticipated)
Study Completion Date
August 27, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genexine, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase 1: sequential dose escalation Phase 2: randomized, placebo controlled, parallel arm
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GX-I7
Arm Type
Experimental
Arm Description
GX-I7 administered until Progression of Disease
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered until Progression of Disease
Intervention Type
Biological
Intervention Name(s)
GX-I7
Intervention Description
Investigational drug
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo drug
Primary Outcome Measure Information:
Title
lymphocyte count
Description
Change in absolute lymphocyte count
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Description
Median overall survival
Time Frame
36 months
Title
Progression free survival
Description
Median progression free survival
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. Vincent Hospital
City
Suwon-si
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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