A Phase II, Multicenter, Open-Label, Single Arm Study of Oral Infigratinib Monotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Who Harboring FGFR2 Gene Amplification
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- LianBio LLC
- 入组人数
- 6
- 试验地点
- 30
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Histologically or cytologically confirmed locally advanced or metastatic gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma.
- •Failed at least 2 lines of prior systemic therapy
- •Willing to undergo tumor biopsy or provide FFPE samples for central lab testing.
- •At least one measurable tumor lesion by RECIST v1.1
- •Eastern cooperative oncology group (ECOG) performance status of 0 or
- •Life expectancy ≥3 months.
- •Willing to participate in this study and sign informed consent form, able to read and understand the study, follow the procedures.
排除标准
- •History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the study.
- •Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
- •Any known hypersensitivity to infigratinib or its excipients.
- •History and/or current evidence of extensive tissue calcification.
- •Current evidence of endocrine alterations of calcium/phosphate homeostasis.
- •Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
- •Laboratory abnormality as defined in protocol.
- •Considered unsuitable to participate in the study by Investigator
研究组 & 干预措施
Infigratinib
Infigratinib 125 mg orally daily, 3 weeks on, 1 week off. . In patients with mild liver function abnormalities or mild renal impairment, the starting dose is 100 mg.
干预措施: Infigratinib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Week9/17/25/33 and every 12 weeks after (up to 2 years)
ORR: the proportion of patients with confirmed complete response (CR) or partial response (PR), assessed by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Duration of response (DoR)
时间窗: Week9/17/25/33 and every 12 weeks after (up to 2 years)
DoR: the duration from the first evaluation as CR or PR to the first evaluation as progressive disease (PD) or death of any cause, per RECIST v1.1 assessed by investigator (INV) and IRC.
Disease control rate (DCR)
时间窗: Week9/17/25/33 and every 12 weeks after (up to 2 years)
DCR: the proportion of patients whose overall response is confirmed to be CR or PR or stable disease (SD) per RECIST v1.1, assessed by INV and IRC.
Overall survival (OS)
时间窗: from the first date of Infigratinib treatment until date of death.
from the first date of Infigratinib treatment until date of death.
Investigator evaluated ORR
时间窗: Week9/17/25/33 and every 12 weeks after (up to 2 years)
the proportion of patients with confirmed CR or PR assessed by INV according to RECIST v1.1
Progression-free survival (PFS)
时间窗: Week9/17/25/33 and every 12 weeks after (up to 2 years)
the duration from the first date of treatment to the date of progression or death due to any cause, assessed by INV and IRC
次要结局
未报告次要终点