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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065087
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

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)

Condition or disease Intervention/treatment Phase
Newly Diagnosed Glioblastoma Biological: GX-I7 Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 1: sequential dose escalation Phase 2: randomized, placebo controlled, parallel arm
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
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
Estimated Study Start Date : August 22, 2019
Estimated Primary Completion Date : May 27, 2022
Estimated Study Completion Date : August 27, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GX-I7
GX-I7 administered until Progression of Disease
Biological: GX-I7
Investigational drug

Placebo Comparator: Placebo
Placebo administered until Progression of Disease
Other: Placebo
Placebo drug




Primary Outcome Measures :
  1. lymphocyte count [ Time Frame: 12 weeks ]
    Change in absolute lymphocyte count


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 36 months ]
    Median overall survival

  2. Progression free survival [ Time Frame: 24 months ]
    Median progression free survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065087


Contacts
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Contact: Yun Jung Choi, Ph.D 82 31 628 3210 yunjung.choi@genexine.com

Locations
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Korea, Republic of
St. Vincent Hospital Recruiting
Suwon-si, Korea, Republic of
Contact: Misun Byun, Ph.D         
Sponsors and Collaborators
Genexine, Inc.
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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT04065087    
Other Study ID Numbers: GX-I7-CA-007
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue