NCT06553365招募中2 期
An Open, Single-Arm Phase II Study Evaluating the Efficacy and Safety of FCN-159 in Selected NF2-associated Nerve Sheath Tumors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) estimated by investigators
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of FCN-159 in patients with specific NF2-associated nerve sheath tumors.
详细描述
- A phase 2 single arm single center study, total 30 patients will be enrolled;
- To evaluate the safety and efficacy of FCN-159, a Mek inhibitor, to treat NF2; associated nerve sheath tumors, age≥16, including benign and malignant tumors;
- Primary endpoint: Objective response rate (ORR)；Secondary Outcome Measures： Clinical benefit rate (CBR)；24w WRS, OS et al..
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥16 years of age, regardless of gender.
- •meet the revised 2022 diagnostic criteria for NF2-associated nerve sheath tumors or pathologically confirmed NF2-associated nerve sheath tumors.
- •should meet one of the following criteria: 1) Incomplete surgical resection, or postoperative recurrence. 2) Systemic therapy is required as determined by the Investigator.
- •the presence of a measurable lesion, as defined by REiNS or RECIST V1.1 criteria.
- •Karnofsky physical status score of ≥
- •the patient has adequate organ and bone marrow function.
- •International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
- •For patients of childbearing potential: During treatment and for at least 90 days after the last dose, patients should agree to use a highly effective method of contraception.
- •avoid excessive sun exposure and be willing to use an adequate amount of sunscreen in anticipation of sun exposure.
- •be able to understand and voluntarily sign a written informed consent form.
排除标准
- •Previously received one of the following treatments:
- •Pharmaceutical or biological therapy within 3 weeks or 5 half-lives prior to enrollment, whichever is longer.
- •Use of growth factors that promote platelet, red blood cell, or white blood cell count or function within 7 days prior to enrollment.
- •Patients who have received major surgery or anti-tumor immunotherapy within 4 weeks prior to enrollment.
- •Radiation therapy for nerve sheath tumors within 4 weeks prior to enrollment.
- •Dose adjustment for patients treated with dexamethasone or other corticosteroids within 1 week prior to enrollment.
- •Patients who have participated in another interventional clinical trial within 4 weeks prior to enrollment.
- •Prior treatment with Selumetinib or any other MEK 1/2 inhibitor.
- •history of or concurrent with other malignancies.
- •inability to undergo MRI and/or contraindications to MRI.
- •uncontrolled hypertension.
- •the presence of dysphagia, active gastrointestinal disease, malabsorption syndrome, or other condition that interferes with the absorption of the study medication.
- •previous or current retinal vascular disease.
- •interstitial pneumonitis
- •cardiac function or co-morbidities
- •Immediate family history of sudden cardiac death before age
- •10.History of any acute neurological condition
- •with active bacterial, fungal or viral infections
- •known hypersensitivity to the study drug, other MEK1/2 inhibitors, or their excipients.
研究组 & 干预措施
FCN-159
Experimental
FCN-159 8mg qd po
干预措施: FCN-159 (Drug)
结局指标
主要结局
Objective response rate (ORR) estimated by investigators
时间窗: Every 4 cycles (each cycle is 28 days), assessed up to 2 years
Investigator-assessed objective mitigation rate ORR (Reponse evaluation in Nerufibromatosis and Schwannomatosis, REiNS criteria and RECIST 1.1 criteria, respectively)
次要结局
- Clinical benefit rate (CBR) estimated by investigators(Every 4 cycles (each cycle is 28 days), assessed up to 2 years)
- 24-week word recognition score (WRS)(up to 24 weeks)
- pain estimated by NRS(Every 4 cycles (each cycle is 28 days), assessed up to 2 years)
- Duration of response (DOR) assessed by investigator(From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
- progression free survival (PFS) assessed by investigator(From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
研究者
研究点 (1)
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