Stomach NeoplasmsPhase 2NCT03170180
Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer
A Phase 2 study testing Sunitinib, Gefitinib and Imatinib in people with Stomach Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
1. Metastatic gastric cancer patients who failed standard treatment will be enrolled in this study. 2. After consent form, patient-derived cancer cell will be collected and tested with 3 kinds of drugs (sunitinib, gefitinib, imatinib). 3. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Sunitinib, Gefitinib and Imatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2017to 28 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- HBeAg, HCV, HIV (+)
- Active infection
- Uncontrolled systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
- Conditions
- Stomach Neoplasms
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
sunitinib 37.5mg daily
GefitinibDrug
Gefitinib 250mg daily
ImatinibDrug
Imatinib 400mg daily
| Study group | Role | What they receive |
|---|---|---|
| sunitinib | Experimental | Not described Receives: Drug: Sunitinib |
| gefitinib | Experimental | Not described Receives: Drug: Gefitinib |
| imatinib | Experimental | Not described Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Mar 2017
- Primary completion31 Oct 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
- Investigators
- Jeeyun Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170180
- Sponsor's protocol ID
- 2016-12-058
- Status last verified
- Jun 2022
- First submitted
- 26 May 2017
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT03170180
- Acronym / sponsor ID
- 2016-12-058
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sunitinib | Experimental | Drug: Sunitinib |
| gefitinib | Experimental | Drug: Gefitinib |
| imatinib | Experimental | Drug: Imatinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age>-20
- metastatic gastric cancer
- life expectancy >-3 months
- ascites and pleural effusion that can be drained
- ECOG 0-2
Key exclusion criteria (3 listed)
- HBeAg, HCV, HIV (+)
- Active infection
- Uncontrolled systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunitinibsunitinib 37.5mg daily | Drug | sunitinib |
| GefitinibGefitinib 250mg daily | Drug | gefitinib |
| ImatinibImatinib 400mg daily | Drug | imatinib |
Primary outcome
response rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeeyun Lee, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib, Gefitinib and Imatinib in people with Stomach Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.