Clinical Trials /

GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

NCT03618667

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.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: SMC2017-06-111
  • NCT ID: NCT03618667

Conditions

  • Glioblastoma, Adult
  • EGFR Amplification

Interventions

DrugSynonymsArms
GC1118single group

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
single groupExperimentalGC1118 (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.
  • GC1118

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival
Time Frame:at 6 months
Safety Issue:
Description:survival time from screening to progression defined by RANO criteria

Secondary Outcome Measures

Measure:overall survival
Time Frame:6 months, 12 month
Safety Issue:
Description:survival time from screening to death of any cause
Measure:overall response rate
Time Frame:up to 30months
Safety Issue:
Description:best overall response rate defined by RANO criteria
Measure:Exploration of predictive/prognostic biomarkers
Time Frame:up to 30 months
Safety Issue:
Description:according to NGS-based biomarkers

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Samsung Medical Center

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