ERibulin in Advanced Solitary Fibrous Tumor, an ItaliaN Sarcoma Group Phase II Study (ERASING)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- RECIST 1.1 Overall response rate
研究概览
简要总结
Phase II study on advanced Solitary Fibrous Tumor (SFT) treated with eribulin
详细描述
This is an Italian, non randomized, open label, multi center, investigator-initiated, Phase II, clinical study to explore the activity of eribulin in a population of patients with progressive, advanced (i.e. locally advanced or metastatic), molecularly proven SFT. Patients with a documented and centrally reviewed pathological diagnosis of locally advanced or metastatic SFT, and with an evidence of progression within the previous 6 months, may enter the study.
Study treatments will be administered till progression or toxicity. The primary end-point of the study is overall response rate Secondary end-points are Progression Free Survival (PFS), Overall Survival (OS) clinical benefit rate, response rate as by Choi criteria, duration of response.
Subjects already treated with one or two prior medical therapy regimens for the advanced phase, whatever agent used in first- or second-line, are eligible for inclusion in the study. Investigators will consider eligible for this study even patients naïve from chemotherapy, considering the limited activity of anthracycline in the disease.
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
- •The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorization before any study-specific procedures, including screening evaluations, sampling, and analyses
- •Age ≥18 years
- •Histological centrally and molecular confirmed diagnosis SFT
- •Locally advanced disease and/or metastatic disease
- •Measurable disease according RECIST 1.1
- •Evidence of progression by RECIST 1.1 during the 6 months before study entry
- •Patients must be 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
- •Adequate organ function
- •Cardiac ejection fraction ≥50%
- •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.
排除标准
- •Naïve patients
- •More than 2 lines of anticancer treatment
- •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 . 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
- •Subjects with a high probability of Long QT Syndrome or corrected QT interval prolongation of more than or equal to 501 msec , 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 according Common Terminology Criteria for Adverse Events (CTCAE) 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 of CTCAE, except for peripheral neuropathy and alopecia.
- •Pre-existing peripheral neuropathy > CTCAE Grade
- •Expected non-compliance to medical regimens
- •Subjects with known central nervous system metastases
研究组 & 干预措施
Eribulin
Eribulin will be administered at the dose of 1.23 mg/m², intravenously over 2-5 min on day 1 and day 8 of every 21 day cycle.
Study treatment will be administered until evidence of progression or unacceptable toxicity, patient's own willingness, non-compliance or according to clinical investigator's decision.
干预措施: Eribulin (Drug)
结局指标
主要结局
RECIST 1.1 Overall response rate
时间窗: At week 6
Proportion of patients with tumor size reduction ⩾ to 30% measured with RECIST Criteria 1.1
次要结局
- Overall Survival (OS) at 3 years(At 3 years)
- Progression Free Survival (PFS) at 3 years(At 3 years)
- Clinical Benefit Rate(At week 18)
- Choi Response Rate(At week 6)
- Safety of the treatment in term of adverse event(Week 9, week 18, week 27, week 36)