Phase 1b Clinical Study of the Safety and Pharmacokinetics of Alofanib in Patients With Metastatic Gastric Cancer Resistant to Standard Therapy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose (MTD) or Recommended phase 2 dose (RP2D)
研究概览
简要总结
This is a non-randomized multicenter phase 1b clinical trial of the safety and pharmacokinetics, as well as the preliminary efficacy of monotherapy with alofanib, an allosteric fibroblast growth factor receptor 2 inhibitor, in patients with advanced gastric cancer who have exhausted the resource of standard therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastric cancer (adenocarcinoma)
- •Progression of the disease (clinical and/or radiological) on previous standard systemic therapy
- •Measurable lesions according to the RECIST 1.1 criteria
- •Possibility to assess the amplification of FGFR2, fusion of FGFR2 genes, overexpression of FGFR2, phosphorylation of FRS2
- •ECOG PS 0-2
- •Age >= 18 years old
- •Adequate function of organs
- •Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study
- •Patients capable of childbearing should use an effective method of contraception
- •Signed Informed Consent
排除标准
- •Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study
- •Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study
- •Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study
- •Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease
- •Pregnancy
- •Known positive status for human immunodeficiency virus (HIV) or active hapatitis B and C
- •Surgery within 7 days before the first dose of the study drug
- •Signs of bleeding or hemorrhagic diathesis
研究组 & 干预措施
Dose cohorts
Part 1 (dose escalation): "3+3" design will be used. Alofanib (dose levels of 50, 100, 165, 250, 350 mg/m2) will be given i.v. daily (1-5 days on, 6-7 days off, every week) till progression or unacceptable toxicity.
Part 2 (dose expansion): Afterwards the dosing regimen identified in Part 1 will be evaluated in a single-arm study focused on clinical efficacy.
干预措施: Alofanib (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) or Recommended phase 2 dose (RP2D)
时间窗: 6 months
The highest dose of an alofanib that does not cause unacceptable side effects and recommended
次要结局
- Tmax(1 month)
- Cmax(1 month)
- t1/2(1 month)
- AUC(1 month)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(12 months)
- CL(1 month)
- Vd(1 month)
- Progression-free survival (PFS)(12 months)
- Overall survival (OS)(12 months)
- Objective response rate (ORR)(12 months)