EUCTR2015-002629-21-IT进行中（未招募）1 期
Phase II study on Regorafenib in advanced Solitary Fibrous Tumor - SOFT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histological centrally confirmed diagnosis of solitary fibrous tumor
- •- 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 Choi criteria
- •- Evidence of progression by Choi during the 6 months before study entry
- •- 1st, 2nd or 3rd line
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
- •- Adequate bone marrow function, defined as the following: WBC >3.0 x 109/L,
- •ANC >1.5 x 109/L, platelets >100 x 109/L, Hb >9 g/dL and blood transfusions to reach the baseline requested Hb level are not allowed
- •- Adequate organ function, defined as the following: total bilirubin <1.5 times the upper limit of normal (except in case of Gilbert’s syndrome), AST (SGOT) and ALT (SGPT) <2.5 x UNL, Lipase = 1.5 x the ULN, creatinine <1.5 x ULN. within normal institutional limits or creatinine clearance 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal; alkaline phosphatase <2.5 x ULN (<5 x upper limit of normal for patients with liver involvement of their cancer and/or have bone metastases); PT-INR/PTT <1.5 x upper limit of normal (Patients who are being therapeutically anti-coagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists).
- •- Cardiac ejection fraction =50% as measured by echocardiogram
- •- Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. 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 and for up to 3 months following discontinuation of study drug.
- •- No history of arterial and/or venous thromboembolic event within the previous 12 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing.
- •- Prior treatment with >3 lines of anticancer agents
- •- 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
- •- 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 administered more than 4 weeks earlier
- •- Major surgery within 4 weeks prior to study entry
- •- Pregnancy
- •- Brest feeding
- •- Inability to swallow oral tablets (crushing of study treatment tablets is not allowed)
- •- Evidence of congestive heart failure classified as New York Heart Association Class 2 or higher
- •- Evidence of unstable angina (angina symptoms at rest) or new-onset angina = 3 months prior to screening.
- •- Medical history of a myocardial infarction < 6 months prior to initiation of study treatment
- •- Arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
- •- Uncontrolled hypertension (systolic blood pressure [SBP] > 140 mmHg or diastolic blood pressure [DBP] > 90 mmHg) despite optimal medical management
- •- 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
- •- Ongoing infection with severity of Grade 2 or above (NCICTCAE v 4.0)
- •- Known history of human immunodeficiency virus infection
- •- Active or chronic hepatitis B or C requiring treatment with antiviral therapy
- •- History of organ allograft
- •- Evidence or history of any bleeding diathesis (including mild hemophilia), irrespective of severity
- •- Medical history of hemorrhage or a bleeding event = Grade 3 (NCI-CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment
- •- Presence of non-healing wound, ulcer, or bone fracture
- •- Renal failure requiring hemodialysis or peritoneal dialysis
- •- Dehydration = Grade 1 (NCI-CTCAE v 4.0)
- •- Interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained
- •- Persistent proteinuria > 3.5 g/24 hours measured by urine protein creatinine ratio from a random urine sample (= Grade 3, NCICTCAE v 4.0)
- •- 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
- •- Presence of any malabsorption condition
- •- Previous radiotherapy to 25 % of the bone marrow
- •- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Regorafenib
- •- Expected non-compliance to medical regimens
研究者
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