Back to resultsExploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sunitinib
Gefitinib
Imatinib
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms
Eligibility Criteria
Inclusion Criteria:
- age>-20
- metastatic gastric cancer
- life expectancy >-3 months
- ascites and pleural effusion that can be drained
- ECOG 0-2
- Proper organ function
- Patients who will be enrolled in sunitinib, gefitinib, imatinib clinical trial
Exclusion Criteria:
- HBeAg, HCV, HIV (+)
- Active infection
- Uncontrolled systemic disease
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
sunitinib
gefitinib
imatinib
Arm Description
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03170180
Brief Title
Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer
Official Title
Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
December 28, 2021 (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
Yes
5. Study Description
Brief Summary
Metastatic gastric cancer patients who failed standard treatment will be enrolled in this study.
After consent form, patient-derived cancer cell will be collected and tested with 3 kinds of drugs (sunitinib, gefitinib, imatinib).
Drug sensitivity prediction software (IRCR-DReSS) will present level of sensitivity and patients will be treated with sensitive drugs.
Patients will be evaluated every 6 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sunitinib
Arm Type
Experimental
Arm Title
gefitinib
Arm Type
Experimental
Arm Title
imatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Intervention Description
sunitinib 37.5mg daily
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Description
Gefitinib 250mg daily
Intervention Type
Drug
Intervention Name(s)
Imatinib
Intervention Description
Imatinib 400mg daily
Primary Outcome Measure Information:
Title
response rate
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age>-20
metastatic gastric cancer
life expectancy >-3 months
ascites and pleural effusion that can be drained
ECOG 0-2
Proper organ function
Patients who will be enrolled in sunitinib, gefitinib, imatinib clinical trial
Exclusion Criteria:
HBeAg, HCV, HIV (+)
Active infection
Uncontrolled systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeeyun Lee, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer
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