NCT03170180

Brief Summary

  1. 1.Metastatic gastric cancer patients who failed standard treatment will be enrolled in this study.
  2. 2.After consent form, patient-derived cancer cell will be collected and tested with 3 kinds of drugs (sunitinib, gefitinib, imatinib).
  3. 3.Drug sensitivity prediction software (IRCR-DReSS) will present level of sensitivity and patients will be treated with sensitive drugs.
  4. 4.Patients will be evaluated every 6 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

4.7 years

First QC Date

May 26, 2017

Last Update Submit

June 13, 2022

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

  • response rate

    2 years

Study Arms (3)

sunitinib

EXPERIMENTAL
Drug: Sunitinib

gefitinib

EXPERIMENTAL
Drug: Gefitinib

imatinib

EXPERIMENTAL
Drug: Imatinib

Interventions

SunitinibDRUG

sunitinib 37.5mg daily

sunitinib
GefitinibDRUG

Gefitinib 250mg daily

gefitinib
ImatinibDRUG

Imatinib 400mg daily

imatinib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • HBeAg, HCV, HIV (+)
  • Active infection
  • Uncontrolled systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

SunitinibGefitinibImatinib Mesylate

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinazolinesBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesPyrimidines

Study Officials

  • Jeeyun Lee, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2017

First Posted

May 30, 2017

Study Start

March 1, 2017

Primary Completion

October 31, 2021

Study Completion

December 28, 2021

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations

KR(1)