KCT0003844已完成未知
An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Safety and Efficacy of INCB054828 in Combination with Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer with Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
已完成
不适用
A study to evaluate the Safety and Efficacy of Nivolumab in Combination with Paclitaxel in Epstein-Barr Virus(EBV)-Related, or Microsatellite Instability-High (MSI-H), or Programmed Cell Death Ligand 1 (PD-L1) Positive Advanced Gastric CancerKCT0004186Yonsei University Health System, Severance Hospital62
招募中
不适用
An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Efficacy of Paclitaxel in Combination with Pembrolizumab and Olaparib as a Second Line Treatment in Immune Checkpoint Inhibitor-experienced Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) CancerNeoplasmsKCT0006101Yonsei University Health System, Severance Hospital77
已完成
不适用
Phase Ib/II Study of M7824 and Paclitaxel Combination in Recurrent/Metastatic Gastric Cancer as a Second-line TreatmentKCT0006078Yonsei University Health System, Severance Hospital49
招募中
1 期
A Single-Arm, Open-Label, Multi-Centre, Phase Ib Study Evaluating the Safety and Preliminary Efficacy of AUTO1 in Pediatric Patients with CD19-Positive Relapsed/ Refractory (r/r) B cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B cell Non-Hodgkin Lymphoma (B NHL)B-cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL).MedDRA version: 21.0Level: LLTClassification code: 10000844Term: Acute lymphoblastic leukaemia Class: 10029104CTIS2023-506307-26-00Autolus Limited24
招募中
Unknown
A multicenter study to evaluate the safety and efficacy of T-DXd in combination with ramucirumab in patients with HER2 low mutations gastric or gastroesophageal junction (GEJ) adenocarcinomaKCT0008627Yonsei University Health System, Severance Hospital58