ISRCTN63733470进行中（未招募）2 期
A randomised phase II multi-centre double-blind placebo-controlled clinical trial of Cediranib in the treatment of patients with Alveolar Soft Part Sarcoma
The Institute of Cancer Research/Royal Marsden Hospital NHS Foundation Trust (UK)0 个研究点目标入组 48 人开始时间: 2011年2月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31160249 (added 05/06/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 11/11/2014:
- •1. Histologically confirmed diagnosis of 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 as defined by RECIST v1.1 within 6 months prior to randomisation
- •7. Measurable metastatic disease using RECIST v1.1, i.e. at least one lesion 10 mm in diameter (15 mm in short axis for nodal lesions) assessable by CT (or MRI for brain metastases).
- •8. Patients with brain metastases are permitted provided disease is controlled with a stable dose of corticosteroid and/or non-enzyme inducing anticonvulsant
- •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
- •Previous inclusion criteria:
- •1. Histologically confirmed diagnosis of ASPS (central confirmation not required at study entry)
- •2. Aged 16 years and older
- •3. Availability of archived tissue blocks or unstained slides to enable confirmation of t(X;17) translocation
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- •5. Life expectancy of greater than 12 weeks
- •6. Progressive disease within 6 months prior to randomisation
- •7. Measurable metastatic disease using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, i.e. at least one lesion 10 mm in diameter (15 mm in short axis for nodal lesions) assessable by spiral computed tomography (CT) (or magnetic resonance imaging [MRI] for brain metastases)
- •8. Patients with brain metastases are permitted provided disease is controlled with a stable dose of corticosteroid and/or non-enzyme inducing anticonvulsant
- •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
- •Current exclusion criteria as of 11/11/2014:
- •1. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count =1.5 x 109/L or platelet count =100 x 109/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/vRR) or history of familial long QT syndrome.
- •10. Significant recent haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5 mL 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. Previous treatment with cediranib.
- •16. Known hypersensitivity to any excipient of cediranib.
- •17. 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.
- •18. Other concomitant anti-cancer therapy (including LHRH agonists) except steroids
- •19. Recent history of thrombosis
- •20. 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.
- •Previous exclusion criteria:
- •1. Inadequate bone marrow reserve
研究者
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