EUCTR2010-021531-13-GB进行中（未招募）1 期
Multi-centre, randomised, double-blind phase II study comparing cediranib (AZD2171) plus gefitinib (Iressa, ZD1839) with cediranib plus placebo in subjects with recurrent/progressive glioblastoma (DORIC Trial) - Phase II trial of cediranib +/- gefitinib for recurrent glioblastoma
Joint UCLH and UCL Biomedical Research Unit0 个研究点目标入组 38 人开始时间: 2011年1月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
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
- •Provision of informed consent
- •Age =18 years
- •Life expectancy = 12 weeks
- •Histological/cytological confirmation of glioblastoma (WHO grade IV)
- •Patients with measurable disease (contrast-enhancing tumour =10 mm by shortest diameter on 2 axial slices) by MRI imaging within 7 days prior to enrolment. (If patients have recently had a routine MRI scan, this should be assessed before deciding whether or not to screen the patient, and booking the screening/baseline MRI.)
- •Patients must have been on no steroids or a stable dose of steroids (dexamethasone) for at least 5 days before the baseline MRI
- •Patients must have completed standard first-line treatment for glioblastoma including surgery (with exception, if patient does not receive surgery as part of first-line treatment due to anatomical location, based on neurosurgeon’s assessment), cranial radiotherapy and chemotherapy with concomitant temozolomide. It is not essential that the entire Stupp regimen of 6 cycles of adjuvant temozolomide following chemoradiotherapy has been completed. The last dose of temozolomide must be more than 28 days from enrolment. Gliadel® wafers are permitted, as it is part of local treatment. No other previous treatment for glioblastoma is permitted (other than steroids).
- •Patients must have a Karnofsky Performance Score of 70 or above
- •Patients must have a mini-mental status examination score of 15 or greater
- •Patients who require either oral anticoagulants (coumadin, warfarin) or low molecular weight heparin are eligible provided there is increased vigilance with respect to monitoring INR.
- •For inclusion in this genetic research, patients must fulfil the following criterion:
- •Provision of informed consent for genetic research (separate consent required for tumour biopsy, blood sample, and post mortem donations)
- •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
- •Patients on enzyme-inducing anti-epileptic drugs within 2 weeks prior to study enrolment. Note: Patients are eligible if they switched to non-enzyme inducing agents and discontinued enzyme-inducing agents for more than or equal to 2 weeks prior to randomisation
- •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 >9g/dL
- •Serum bilirubin =1.5 x ULRR (Upper Limit of the Reference Range)(except for patients with known documented cases of Gilbert’s Syndrome)
- •ALT or AST =5 x ULRR
- •Serum creatinine >1.5 x ULRR or a creatinine clearance of =50mL/min calculated by Cockcroft-Gault
- •Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein <1.5g in a 24 hr period or UPC (Urine Protein: Creatinine) ratio <1.5
- •History of significant gastrointestinal impairment, as judged by the investigator, that would significantly affect the absorption of cediranib or gefitinib, including the ability to swallow the tablet whole
- •Patients with a history of poorly controlled hypertension with resting blood pressure >150/100mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilise blood pressure
- •Any evidence of severe or uncontrolled diseases (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •Unresolved toxicity >CTC AE grade 1 from previous anti-cancer therapy (including radiotherapy) except alopecia (if applicable)
- •Mean QTc with Bazetts correction >470msec in screening ECG or history of familial, long QT syndrome
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Significant haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
- •Recent (<14 days) major surgery or brain biopsy. Recent craniotomy (<28 days) prior to first dose, 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 cediranib, gefitinib or any of its excipients
- •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 they have tissue diagnosis of the target lesion
- •Known infection with hepatitis B or C or HIV
- •Involvement in the planning and conduct of the study (applies to both UCL CTC, AstraZeneca staff and staff at the study site)
- •Past medical history of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
- •Previous enrolment as part of the present study
- •Treatment with an investigational drug within 30 days prior to the first dose of cediranib/gefitinib
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