None listed
Conditions
Interventions
Drug : 1 phase>
- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four wee
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who agreed in writing to the clinical study consent 2. Histologically or cytologically confirmed advanced gastric adenocarcinoma. Patients must have experienced objective radiological or disease progress with evidence during or after primary therapy with fluoropyrimidine and platinum. 3. FGFs / FGFRs have genetic variation on NGS. 4. Patients whose life expectancy is at least 3 months 5. If the Eastern Cooperative Oncology Group (ECOG) is 0 or 1 6. Measurable or assessable lesion based on RECIST 1.1 scale 7. Must be swallowed, should be able to take oral medication 8. Possible long-term function to receive chemotherapy. 9. Patients receiving anti-HER2 therapy for HER2 negative or HER2-positive primary treatment
Exclusion criteria
Exclusion criteria: 1. When chemotherapy exceeded the first treatment 2. Patients with multiple cancers 3. Severe hypersensitivity reactions to anti-FGFR2 agents either now or in the past 4. Patients with endocrine metabolic syndrome or history of calcium-phosphate homeostasis 5. Patients with ectopic neoplasm or history of soft tissue, kidney, large intestine, heart, or abdomen 6. Corneal lesions such as bullous keratopathy, corneal erosion, corneal erosion, corneal ulcer, corneal inflammation and keratoconjunctivitis were confirmed by ophthalmic examination 7. Patients with metastasis to the brain or meninges. However, patients who do not have symptoms and do not need treatment can register. 8. Clinically significant digestive system problems that can cause abnormalities in taking or absorbing clinical drugs 9. Patients with uncontrollable or significant cardiovascular disease 10. Patients with systemic infections requiring treatment 11. Patients who were exposed to paclitaxel at or before the taxane 12. If you undergo major surgery within 28 days before enrollment for this trial 13. Patients who received radiotherapy for gastric cancer within 28 days prior to enrollment for this trial. However, the investigation of bone turnover was conducted within 14 days before the registration for this trial 14. If you received general chemotherapy within 14 days of enrollment for this trial 15. Patients who are positive for human immunodeficiency virus (HIV-1) antibody test, 16. HBsAg results positive, HBV viral load greater than 2000 IU / ml (104 copies / ml), or HCV antibody test positive 17. Patients who are pregnant, lactating, or are likely to be pregnant 18. Anemia and hair loss are excluded if previous chemotherapy treatment has toxicity that is not recovered below grade 2. 19. Patients who are judged to have lost their ability to cope with dementia or other comorbid conditions 20. Other Patients who the examiner or the examiner deemed inappropriate for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximal tolerated dose (MTD) schedule for the combination of INCB054828 and paclitaxel;To determine the recommended Phase 2 dose (RP2D) schedule of INCB054828 and paclitaxel combination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adeverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactSun young Rha
Yonsei University Health System, Severance Hospital
Outcome results
None listed