NCT06880848已完成4 期
A Prospective, Open-Label, Single-Arm, Multi-Center, Phase IV Efficacy and Safety Study of Sonidegib in Adult Patients With Locally Advanced Basal Cell Carcinoma (laBCC) in China
Jemincare1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年6月21日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a Phase IV, single arm, multicenter study designed to evaluate the efficacy and safety profile of Sonidegib in chinese participants with locally advanced basal cell carcinoma (laBCC) who are not amenable to radiation therapy, curative surgery or other local therapies.
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
- •Age 18 years or older.
- •Patients with a histologically confirmed diagnosis of laBCC that is not amenable to radiation therapy, curative surgery, or other local therapies. Patients with laBCC must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥ 10 mm, with MRI/CT scan or on color photographs.
- •ECOG PS Score ≤
- •Patients with adequate bone marrow, liver and renal function.
- •Written informed consent obtained prior to any screening procedures.
- •Patients are willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions.
- •Females of childbearing potential agree to use contraception during treatment and for 20 months following the last dose; male patients (even after vasectomy) agree to use contraception during treatment and for 8 months after the last dose.
排除标准
- •Subjects in the opinion of the investigator are immunosuppressed (e.g., organ transplant recipients, HIV, systemic invasive malignancy within past 5 years excluding Stage I cervical cancer, ductal carcinoma in situ of the breast or CLL stage 0, graft vs. host disease, etc.).
- •LaBCC patients with skin lesions in multiple body locations will not be considered metastatic patients. LaBCC patients with positive (histological confirmation of BCC) regional nodal disease will be considered to have metastatic disease.
- •Poorly controlled diabetes mellitus (as per Investigator's discretion in consultation with Sponsor's medical monitor).
- •Major surgery within 4 weeks prior to study treatment.
- •Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data.
- •Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes.
- •Patients who have previously been treated with systemic Sonidegib or with other Hh pathway inhibitors.
- •Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy).
- •Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment.
- •Have participated in other clinical trials within 4 weeks prior to the first dose of sonidegib.
- •Have received other anti-neoplastic therapy within 4 weeks prior to study treatment.
- •Patients who are receiving medications known to be moderate and strong inhibitors or inducers of cytochrome P450 (CYP) 3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with sonidegib. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with sonidegib.
- •Pregnant or nursing (lactating) women, confirmed by a positive hCG laboratory test (> 5mIU/mL).
- •Unwilling or unable to comply with the protocol.
研究组 & 干预措施
Sonidegib Phosphate Capsules
Experimental
Participants will receive continuous treatment with oral administration once a day until conditions for treatment termination are met.
干预措施: Sonidegib Phosphate Capsules (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 1 year
Objective response rate (ORR) is defined as the percentage of participants with a confirmed complete or partial response (CR or PR) , per modified Response Evaluation Criteria in Solid Tumors (mRECIST) as assessed by central review.
次要结局
- Duration of Response (DoR)(up to 1 year)
- Complete response rate (CRR) per central and investigator review(up to 1 year)
- Progression-free Survival (PFS)(up to 1 year)
- Time to tumor response (TTR)(up to 1 year)
- Adverse event (AE)/Serious adverse event (SAE)/Treatment emergent adverse event (TEAE)(up to 1 year)
研究者
研究点 (1)
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