ACTRN12612000020886招募中2 期
A phase II trial of cediranib in the treatment of patients with alveolar soft part sarcoma (CASPS)
The Institute of Cancer Research / Royal Marsden Hospital NHS Foundation Trust (UK)0 个研究点目标入组 36 人开始时间: 2012年1月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Histologically confirmed diagnosis of Alveolar Soft Part Sarcoma (ASPS)(central confirmation not required at study entry)
- •2. Age 16 years and older
- •3. Availability of archived tissue blocks to enable confirmation of t(X;17) translocation
- •4. ECOG Performance Status of 0-1
- •5. Life expectancy of >12 weeks
- •6. Progressive disease within 6 months prior to randomisation
- •7. Measurable metastatic disease using RECISTv1.1, i.e. at least one lesion 10mm in diameter (15mm in short axis for nodal lesions) assessable by spiral CT (or MRI for brain metastases)
- •8. Patients with brain metastases are permitted provided disease is controlled with a stable dose of coricosteroid and/or non-enzyme inducing anticonvulsent
- •9. The capacity to understand the patient information sheet and ability to provide written informed consent
- •10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- •11. Able to swallow and retain oral medication
排除标准
- •1. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count <=1.5 x 10^9/L or platelet count <=100 x 10^9/L
- •2. Serum bilirubin <=1.5 x ULN (unless Gilbert’s syndrome)
- •3. ALT or AST >= 2.5 x ULN. If liver metastases are present, ALT or AST > 5 x ULN
- •4. Serum creatinine > 1.5 x ULN or a creatinine clearance (calculated or measured) of <=50mL/min
- •5. Greater than +1 proteinuria unless urinary protein < 1.5g in a 24 hr period or protein/creatinine ratio < 1.5
- •6. History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib
- •7. Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy
- •8. Any evidence of severe or uncontrolled co-morbidities e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, or active and uncontrolled infection
- •9. Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/sqRR) or history of familial long QT syndrome
- •10. Significant recent haemorrhage (>30mL bleeding/ episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
- •11. Major thoracic or abdominal surgery in the 14 days prior to entry into the study, or a surgical incision that is not fully healed
- •12. Pregnant or breast-feeding women; women of childbearing potential with a positive pregnancy test prior to receiving study medication; women the intention of pregnancy during study treatment; women of child bearing potential unwilling to have a urine or serum pregnancy test prior to study entry (even if surgically sterilised)
- •13. Men and women of childbearing potential unwilling to use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with
- •spermicide, implantable or injectable contraceptives or surgical sterilisation) for the duration of the study and should continue such precautions for 2 weeks after receiving
- •the last study treatment
- •14. History of anticancer (including investigational, non-registered) treatment in the four weeks prior to first dose of cediranib, with the exception of palliative radiotherapy for
- •symptom control
- •15. Known hypersensitivity to cediranib or any of its excipients
- •16. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the primary cancer of interest from a target lesion
- •17. Other concomitant anti-cancer therapy (including LHRH agonists) except steroids
- •18. Recent history of thrombosis
- •19. Patients with brain metastases if they are symptomatic requiring increasing steroids in the previous six weeks to study entry or those with evidence of recent and/or active
- •bleeding, or those causing uncontrolled seizures
研究者
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