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GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

Primary Purpose

Glioblastoma, Adult, EGFR Amplification

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC1118
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma, Adult

Eligibility Criteria

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

Inclusion Criteria:

  1. written informed consent
  2. 19 years or older
  3. patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
  4. high EGFR amplification
  5. available archive tumor sample(s)
  6. Karnofsky performance status (KPS) > 70
  7. life expectancy > 3 months
  8. adequate end-organ function
  9. patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)

Exclusion Criteria:

  1. patients who had EGFR target agent(s) before screening
  2. patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease)
  3. patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
  4. patients who had investigation drug(s) within previous 4 weeks
  5. patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer)
  6. patients who had severe infection within previous 4 weeks
  7. HIV infection
  8. patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks
  9. clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)
  10. pregnancy or breast-feeding

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single group

Arm Description

GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles, or till progression or uncontrolled toxicity.

Outcomes

Primary Outcome Measures

Progression-free survival
survival time from screening to progression defined by RANO criteria

Secondary Outcome Measures

overall survival
survival time from screening to death of any cause
overall response rate
best overall response rate defined by RANO criteria
Exploration of predictive/prognostic biomarkers
according to NGS-based biomarkers(whole exome sequencing and whole transcriptome sequencing)

Full Information

First Posted
July 7, 2018
Last Updated
May 11, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03618667
Brief Title
GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification
Official Title
A Phase II Clinical Study of GC1118 in Recurrent Glioblastoma Patients With High Epidermal Growth Factor Receptor (EGFR) Amplification
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
September 8, 2018 (Actual)
Study Completion Date
April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

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

5. Study Description

Brief Summary
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
Detailed Description
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation. GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Adult, EGFR Amplification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single group
Arm Type
Experimental
Arm Description
GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles, or till progression or uncontrolled toxicity.
Intervention Type
Drug
Intervention Name(s)
GC1118
Intervention Description
GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycles) up to 6 cycles, or till progression or uncontrolled toxicity.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
survival time from screening to progression defined by RANO criteria
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
overall survival
Description
survival time from screening to death of any cause
Time Frame
6 months, 12 month
Title
overall response rate
Description
best overall response rate defined by RANO criteria
Time Frame
up to 30months
Title
Exploration of predictive/prognostic biomarkers
Description
according to NGS-based biomarkers(whole exome sequencing and whole transcriptome sequencing)
Time Frame
up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: written informed consent 19 years or older patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide) high EGFR amplification available archive tumor sample(s) Karnofsky performance status (KPS) > 70 life expectancy > 3 months adequate end-organ function patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1) Exclusion Criteria: patients who had EGFR target agent(s) before screening patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease) patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks patients who had investigation drug(s) within previous 4 weeks patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer) patients who had severe infection within previous 4 weeks HIV infection patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc) pregnancy or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sehoon lee, professor
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

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