Back to resultsBiomarker-Integrated Umbrella, Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Active
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
biomarker screening
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Male or female; ≥ 19 years of age
- On or progression after 1st line palliative chemotherapy
- Subjects with evaluable lesion (using RECIST 1.1 criteria)
Subjects who meet the following criteria:
- Absolute neutrophil count ≥ 1000 /µL
- Platelet count ≥ 75,000/ µL
- Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min
- aspartate aminotransferase and alanine transaminase 3 x upper limit of normal
Exclusion Criteria:
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Sites / Locations
- Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
biomarker group
control group
Arm Description
400 Her-2 (-) metastatic/recurrent gastric cancer patients will be centrally screened for druggable targets [Epstein-Barr virus, Microsatellite instability, HER2, EGFR, c-MET, and PTEN] by immunohistochemistry and in situ hybridization during first line chemotherapy. At the time of second line treatment, patients will be randomized to the biomarker vs control group as 4: 1 ratio. The biomarker group will be offered for entry into a specific protocol based on their molecular cohort and treated with specific targeted agents in combination with weekly paclitaxel; 1) EGFR cohort (EGFR 2+ or EGFR 3+) for pan-ERBB inhibitor (afatinib), 2)PTEN loss cohort (PTEN score less than 100) for PIK3CB inhibitor (GSK2636771), 3) PD-L1 positive, MSI-high, or EBV positive cases for nivolumab, 4) none for weekly paclitaxel.
Patients will be randomized to the biomarker vs control group (standard of care; paclitaxel) as 4:1 ratio.
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02951091
Brief Title
Biomarker-Integrated Umbrella, Advanced Gastric Cancer
Official Title
The Master Protocol for Biomarker-Integrated Umbrella Trial in Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
Brief Summary
In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Biomarker-integrated multi-arm with shared standard of care (SOC) control arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
biomarker group
Arm Type
Experimental
Arm Description
400 Her-2 (-) metastatic/recurrent gastric cancer patients will be centrally screened for druggable targets [Epstein-Barr virus, Microsatellite instability, HER2, EGFR, c-MET, and PTEN] by immunohistochemistry and in situ hybridization during first line chemotherapy. At the time of second line treatment, patients will be randomized to the biomarker vs control group as 4: 1 ratio. The biomarker group will be offered for entry into a specific protocol based on their molecular cohort and treated with specific targeted agents in combination with weekly paclitaxel; 1) EGFR cohort (EGFR 2+ or EGFR 3+) for pan-ERBB inhibitor (afatinib), 2)PTEN loss cohort (PTEN score less than 100) for PIK3CB inhibitor (GSK2636771), 3) PD-L1 positive, MSI-high, or EBV positive cases for nivolumab, 4) none for weekly paclitaxel.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients will be randomized to the biomarker vs control group (standard of care; paclitaxel) as 4:1 ratio.
Intervention Type
Other
Intervention Name(s)
biomarker screening
Intervention Description
immunohistochemistry and in situ hybridization
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
Eastern Cooperative Oncology Group performance status of 0 to 1
Male or female; ≥ 19 years of age
On or progression after 1st line palliative chemotherapy
Subjects with evaluable lesion (using RECIST 1.1 criteria)
Subjects who meet the following criteria:
Absolute neutrophil count ≥ 1000 /µL
Platelet count ≥ 75,000/ µL
Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min
aspartate aminotransferase and alanine transaminase 3 x upper limit of normal
Exclusion Criteria:
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Young Rha, Ph.D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Biomarker-Integrated Umbrella, Advanced Gastric Cancer
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