EUCTR2005-003442-33-GB进行中（未招募）1 期
A Phase II, Randomised, Factorial, Double-blind Study to Investigate the Management of AZD2171-induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients with Advanced Solid Tumours
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
入选标准
- •1. Provision of written informed consent.
- •2. Males or females aged 18 years and older.
- •3. Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a VEGFR tyrosine kinase inhibitor.
- •4. World Health Organisation (WHO) Performance score 0-2.
- •5. Life expectancy of >12 weeks.
- •6. One or more measurable lesions at least 10 mm in the longest diameter by spiral computed tomography (CT) scan or 20 mm with conventional techniques (as defined by RECIST).
- •7. Patients considered by the investigator to be suitable for orally administered treatment.
- •For inclusion in the genetic research component of the study, patients must fulfil the following criterion:
- •1. Provision of informed consent for genetic research.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Untreated unstable brain or meningeal metastases. Patients with radiological evidence of stable brain metastases are eligible providing that they are asymptomatic and either:
- •a. do not require corticosteroids or
- •b. have been treated with corticosteroids, with clinical and radiological evidence of brain metastases stabilisation at least 10 days after discontinuation of steroids.
- •2. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count <1.5 x 109/L or platelet count <100 x 109/L or requiring regular blood transfusions to maintain haemoglobin >9 g/dL.
- •3. Serum bilirubin >1.5 x upper limit of reference range (ULRR).
- •4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULRR. If liver metastases are present, ALT or AST >5 x ULRR.
- •5. Serum creatinine >1.5 x ULRR or a creatinine clearance of <50mL/min calculated by Cockcroft-Gault.
- •6. Greater than +1 proteinuria on 2 consecutive dipsticks taken no less than 1 week apart or if urinary protein >1.5 g in a 24-hour urine collection.
- •7. Patients with a history of poorly controlled hypertension with resting BP >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy. Measurements will be made after the patient has been resting supine for a minimum of 5 minutes. Two or more readings should be taken at 2 minute intervals and averaged. If the first 2 diastolic readings differ by more than 5 mmHg then an additional reading should be obtained, and averaged.
- •8. Patients who are currently receiving maximal doses of calcium-channel blockers or more than 1 anti-hypertensive for the treatment of hypertension.
- •9. Any evidence of severe or uncontrolled systemic diseases (eg, unstable or uncompensated respiratory, cardiac including arrhythmias, hepatic or renal disease), including known infection with Hepatitis B or C virus or human immunodeficiency virus.
- •10. Unresolved toxicity >CTC grade 2 from previous anti-cancer therapy except alopecia (if applicable).
- •11. Mean QTc with Bazett’s correction >470 msec in screening electrocardiogram (ECG) or history of familial long QT syndrome (as per International Conference on Harmonisation [ICH] guideline E14).
- •12. Significant haemorrhage (>30 ml bleeding/episode in previous 3 months) or haemoptysis (>5 ml fresh blood in previous 4 weeks).
- •13. Recent (<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed.
- •14. Pregnant or breast-feeding women or women of childbearing potential with a positive pregnancy test prior to receiving study medication.
- •15. Known severe hypersensitivity to AZD2171 or any of its excipients.
- •16. Other concomitant anti-cancer therapy, except steroids or hormone therapy for prostate cancer (eg, Zoladex).
- •17. Known severe hypersensitivity to beta-blockers or calcium-channel blockers.
- •18. History of other malignancies within 5 years except for adequately treated basal or squamous cell cancer or carcinoma in situ.
- •19. History of CNS disorders or uncontrolled seizures.
- •20. History of significant gastrointestinal impairment, as judged by the investigator that
研究者
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