2024-517795-38-00招募中2 期
ERibulin in Advanced Solitary fibrous tumor, an ItaliaN sarcoma Group phase II study (ERASING)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Overall tumor Response Rate, according to RECIST v 1.1
研究概览
简要总结
The primary objective of this study is to explore the activity of eribulin in 2nd or 3rd line, in adult patients with advanced Solitary Fibrous Tumour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Isg-erasing
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •The patient or legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses
- •Adequate organ function
- •Cardiac ejection fraction ≥50% as measured by echocardiogram
- •Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
- •Age ≥18 years
- •Histological centrally and molecularly confirmed diagnosis of STAT6 positive solitary fibrous tumor (inclusive of the last available tumor sample or fresh biopsy); a paraffin embedded tumor block is required.
- •Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
- •Measurable or evaluable disease with RECIST 1.1
- •Evidence of progression by RECIST 1.1 during the 6 months before study entry
- •Patients must be pre-treated with at least one prior medical anticancer treatment line for the advanced phase of disease (both cytotoxic chemotherapy or target treatment allowed) and with a maximum of 2 lines.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- •Adequate bone marrow function
排除标准
- •Naïve patients
- •Subjects with a high probability of Long QT Syndrome or QTc interval prolongation of more than or equal to 501 msec on at least two separate electrocardiograms (ECGs), following correction of any electrolyte imbalance
- •Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
- •Known history of human immunodeficiency virus infection
- •Active or chronic hepatitis B or C requiring treatment with antiviral therapy
- •Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI‐CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment
- •Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results
- •Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
- •Subjects who have not recovered from acute toxicities as a result of prior anti-cancer therapy to ≤ Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE), except for peripheral neuropathy (see Exclusion 18) and alopecia.
- •Pre-existing peripheral neuropathy > CTCAE Grade
- •Expected non-compliance to medical regimens
- •>2 line of anticancer treatment
- •Subjects with known central nervous system (CNS) metastases.
- •Previous treatment with any other anti-cancer investigational or not investigational agents within 21 days of first day of study drug dosing
- •Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
- •Previous radiotherapy to 25 % of the bone marrow
- •Major surgery within 21 days prior to study entry
- •Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
- •Pregnancy or breast feeding
- •Cardiovascular diseases resulting in a New York Heart Association Functional Status >2 (24). Medical history of a myocardial infarction < 6 months prior to initiation of study treatment. Unstable angina or myocardial infarction within 6 months of enrolment, Serious and potentially life-threatening arrhythmia
结局指标
主要结局
Overall tumor Response Rate, according to RECIST v 1.1
Overall tumor Response Rate, according to RECIST v 1.1
次要结局
- Choi Response Rate
- Overall Survival (OS)
- Progression Free Survival (PFS)
- Clinical Benefit Rate
- Duration of response
- Safety
研究者
Silvia Stacchiotti
Scientific
Italian Sarcoma Group
研究点 (3)
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