ISRCTN00549973已完成2 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)
niversity College London (UK)0 个研究点目标入组 38 人开始时间: 2011年5月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
研究概览
简要总结
2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27232884 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provision of informed consent
- •2. Age =18 years
- •3. Life expectancy = 12 weeks
- •4. Histological/cytological confirmation of glioblastoma (WHO grade IV)
- •5. 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.)
- •6. Patients must have been on no steroids or a stable dose of steroids (dexamethasone) for at least 5 days before the baseline MRI
- •7. 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
- •7.1. It is not essential that the entire Stupp regimen of 6 cycles of adjuvant temozolomide following chemoradiotherapy has been completed
- •7.2. The last dose of temozolomide must be more than 28 days from enrolment
- •7.3. Gliadel® wafers are permitted, as it is part of local treatment
- •7.4. No other previous treatment for glioblastoma is permitted (other than steroids)
- •8. Patients must have a Karnofsky Performance Score of 70 or above
- •9. Patients must have a mini-mental status examination score of 15 or greater
- •10. 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.
- •11. For inclusion in the genetic research, patients must fulfil the following criterion:
- •11.1. Provision of informed consent for genetic research (separate consent required for tumour biopsy, blood sample, and post mortem donations)
- •11.2. If a patient declines to participate in any of the genetic research, there will be no penalty or loss of benefit to the patient
- •11.3. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to the main study
排除标准
- •1. 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
- •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 >9g/dL
- •3. Serum bilirubin =1.5 x ULRR (except for patients with known documented cases of Gilbert?s Syndrome)
- •4. 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 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
- •7. 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
- •8. 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
- •9. Any evidence of severe or uncontrolled diseases (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •10. Unresolved toxicity >CTC AE grade 1 from previous anti-cancer therapy (including radiotherapy) except alopecia (if applicable)
- •11. Mean QTc with Bazetts correction >470msec in screening ECG or history of familial, long QT syndrome
- •12. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •13. Significant haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
- •14. Recent (<14 days) major surgery or brain biopsy
- •15. Recent craniotomy (<28 days) prior to first dose, or a surgical incision that is not fully healed
- •16. Pregnant or breast-feeding women or women of childbearing potential with a positive pregnancy test prior to receiving study medication
- •17. Known hypersensitivity to cediranib, gefitinib or any of its excipients
- •18. 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
- •19. Known infection with hepatitis B or C or HIV
- •20. Involvement in the planning and conduct of the study (applies to both UCL CTC, AstraZeneca staff and staff at the study site)
- •21. 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
- •22. Previous enrolment as part of the present study
- •23. Treatment with an investigational drug within 30 days prior to the first dose of cediranib/gefitinib
研究者
相似试验
已完成
3 期
A multicentre, phase III, randomised, double-blind, placebo-controlled trial of pravastatin added to first-line chemotherapy in patients with small cell lung cancerLung cancerSmall cell lung cancerCancerISRCTN56306957niversity College London (UK)860
已完成
2 期
stekinumab in adolescents with recent-onset type 1 diabetesNutritional, Metabolic, EndocrineType 1 diabetes mellitusISRCTN14274380Cardiff University88
已完成
2 期
The efficacy, safety and tolerability of PSD502 in subjects with premature ejaculation (PE)Premature ejaculationISRCTN57186091Plethora Solutions Ltd (UK)256
进行中（未招募）
2 期
A clinical trial of 5 mg psilocybin plus psychological support vs 25 mg psilocybin plus psychological support in adults with generalised anxiety disorderGeneralised anxiety disorderMental and Behavioural DisordersISRCTN14487299Incannex Healthcare Limited96
已完成
3 期
Effects of ethyl lauroyl arginine nasal spray on COVID-19COVID-19 (SARS-CoV-2 infection)Infections and InfestationsISRCTN17834262Salvacion LLC30