EUCTR2005-003441-13-GB进行中（未招募）1 期
A Two-part, Open-label, Multi-centre, Phase II Study in Patients with Advanced Solid Tumours, Consisting of a Randomised 2-period Crossover Protocol to Determine the Effect of Food upon the Pharmacokinetics of a Single Oral Dose of AZD2171 (Part A), Followed by a Randomised, Parallel-group Protocol to Assess the Safety, Tolerability and Efficacy of Multiple Doses of AZD2171 Administered as Either a Fixed Daily Dose of 45mg or an Individualised Dose Escalation Plan (Part B).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •For inclusion in the study, patients must fulfil all of the following criteria:
- •Provision of written informed consent.
- •Males or females aged 18 years or older.
- •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.
- •World Health Organisation (WHO) performance status 0 2.
- •Life expectancy =12 weeks.
- •One or more measurable lesions at least 10 mm in the longest diameter by spiral computed tomography scan or 20 mm with conventional techniques (as defined by RECIST).
- •Ability to consume a Food and Drug Administration high fat breakfast (see Appendix D).
- •Patients considered by the investigator to be suitable for orally administered treatment.
- •For inclusion in the genetic research component of this study, patients must fulfil the following criterion:
- •Provision of informed consent for genetic research
- •If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to these aspects.
- •For inclusion in the DC MRI research component of this study, patients must fulfil the following criterion:
- •Presence of liver metastases or tumours (2 10 cm) or, in the absence of liver lesions, other tumour sites deemed assessable by the investigator (2 10 cm) by DCE MRI.
- •If a patient declines to participate in the DCE MRI research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to these aspects.
- •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
- •Any of the following is regarded as a criterion for exclusion from the study:
- •Untreated unstable brain or meningeal metastases. Patients with radiological evidence of stable brain metastases are eligible providing that they are asymptomatic and either:
- •do not require corticosteroids or
- •have been treated with corticosteroids, with clinical and radiological evidence of stabilisation at least 10 days after discontinuation of steroids.
- •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.
- •Serum bilirubin =1.5 x upper limit of reference range (ULRR).
- •Alanine amino transferase (ALT) or aspartate aminotransferase (AST) =2.5 x ULRR. If liver metastases are present, ALT or AST >5 x ULRR.
- •Serum creatinine >1.5 x ULRR or a creatinine clearance of =50 mL/min calculated by Cockcroft-Gault.
- •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.
- •Patients with a history of poorly controlled hypertension with resting BP >150/100 mmHg in the presence or absence of a stable regimen of 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, an additional reading should be obtained and averaged.
- •Any evidence of severe or uncontrolled systemic diseases (eg, unstable or uncompensated respiratory, cardiac including arrhythmias, hepatic or renal disease), including the known risk of the patient transmitting HIV or hepatitis B or C via infected blood.
- •Any unresolved toxicity > CTC grade 1 from previous anti-cancer therapy (including radiotherapy) except alopecia (if applicable). For haemoglobin, refer to exclusion criteria number 2.
- •Mean QTc with Bazetts correction (QTcB) >470msec in screening ECG or history of familial long QT syndrome:
- •a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 ms)
- •a history of additional risk factors for Torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- •The use of concomitant medications that prolong the QT/QTc interval.
- •Significant haemorrhage (>30 mL bleeding/episode in previous 3 months) or haemoptysis (>5 mL fresh blood in previous 4 weeks).
- •Recent (<14 days) major surgery prior to entry into the study or a surgical incision that is not fully healed.
- •Pregnant or breast-feeding women or women of childbearing potential with a positive pregnancy test prior to receiving study medication.
- •Known hypersensitivity to AZD2171 or any of its excipients.
- •Other concomitant anti-cancer therapy, except steroids or luteinising hormone releasing hormone agonist therapy for prostate cancer (eg, Zoladex).
- •Known severe hypersensitivity to beta-blockers or calcium-channel blockers.
- •History of other malignancies within 5 years except for adequately treated basal or squamous c
研究者
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