ACTRN12608000158369进行中（未招募）1 期
A Phase Ib/II Study of CYT997 in Combination with Carboplatin in Relapsed Glioblastoma Multiforme: Assessing Safety and Tolerability.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Patients must have histologically-confirmed glioblastoma multiforme that has
- •progressed after initial surgery, radiation therapy and temozolomide chemotherapy.
- •Measurable tumour must be present on gadolinium-enhanced magnetic resonance imaging (MRI)
- •At least 3 months must have elapsed from completing radiation to minimize the
- •possibility of pseudo-progression.
- •At least 4 weeks since prior chemotherapy (6 weeks if the last regimen included carmustine (BCNU) or lomustine (CCNU)).
- •Age = 18 years.
- •If patients are taking steroids, the dose must be stable for = 7 days.
- •Eastern Co-operative Oncology Group (ECOG) performance status = 2.
- •Life expectancy of greater than 2 months.
- •Patients must have adequate organ and marrow function as defined below:
- •o Absolute neutrophil count = 1.5 × 109/L
- •o Platelet count = 100 × 109/L
- •o Total bilirubin within normal limits
- •o Liver enzymes (Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) < 5 × upper limit of normal (ULN)
- •o Creatinine within normal limits OR creatinine clearance = 60 mL/min/1.73 m2 for
- •patients with creatinine levels above normal
- •o Normal left ventricular ejection fraction on a gated blood pool scan or
- •echocardiogram
- •Must agree to use adequate contraceptive measures if indicated
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who have received any other investigational agent in the preceding four weeks prior to commencing therapy in this study.
- •Patients who have been previously treated with carboplatin.
- •Patients who have been previously treated with bevacizumab or other anti-angiogenesis or vascular-disrupting agents.
- •Patients who are receiving enzyme-inducing anticonvulsant drugs (EIACD) such as phenytoin or carbamazepine.
- •Patients with a history of allergic reactions attributed to compounds of similar chemical composition to CYT997 or other agents used in the study.
- •Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or lactating women.
- •Patients with immune deficiency, including Human Immunodeficiency Virus (HIV) -positive patients.
- •Patients with uncontrolled diarrhoea despite optimal medication and those with any history of acute gastrointestinal bleeding.
- •Patients who are unable or unwilling to undergo MRI scanning.
- •Patients with the following conditions/treatments will be excluded:
- •Myocardial infarction within 6 months;
- •History of stroke or transient ischemic attacks (TIAs);
- •Unstable angina pectoris or acute ischemic changes on ECG;
- •History of diabetic retinopathy;
- •Symptomatic peripheral arterial disease;
- •Major surgery in the last 4 weeks;
- •Evidence of intra-tumoural haemorrhage on imaging, except for stable grade-1 post-operative haemorrhage;
- •Current therapeutic anti-coagulation with warfarin or a heparin (excludes low-dose prophylactic heparin);
- •Uncontrolled hypertension;
- •The need for any anti-arrhythmic drugs.
- •Presence of luminal stenosis of 50% or more in any of the extracranial or intracranial arteries supplying the brain, as measured by magnetic resonance angiography (MRA) at baseline.
- •Patients with a baseline prolongation of the QTc interval of Common Toxicity Criteria (CTC) grade 1 (QTc > 0.45-0.47 sec) or greater.
- •Patients with impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
- •Left Ventricular Ejection Fraction (LVEF) < 45% as determined by Multigated Acquisition (MUGA) scan or echocardiogram;
- •complete left bundle branch block;
- •obligate use of a cardiac pacemaker;
- •congenital long QT syndrome;
- •history or presence of ventricular tachyarrhythmia;
- •presence of unstable atrial fibrillation (ventricular response > 100 bpm). Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria;
- •clinically significant resting bradycardia (< 50 bpm);
- •right bundle branch block + left anterior hemiblock (bifasicular block);
- •angina pectoris = 3 months prior to starting study drug;
- •acute MI = 3 months prior to starting study drug; or
- •other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
- •Patients currently receiving treatment with medications known to prolong the QTc interval and/or to induce Torsades de Pointes arrhythmia
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