EUCTR2013-001017-33-GB进行中（未招募）1 期
A phase I trial of Vandetanib combined with 131I-mIBG Radiotherapy in patients with Neuroendocrine Tumours, advanced phaeochromocytoma and paraganglioma - VIBRaNT
niversity College London0 个研究点目标入组 18 人开始时间: 2014年2月17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
- 18
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
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. A histopathological or cytological diagnosis of advanced phaeochrmocytoma/ paraganglioma defined as patients with local or metastatic disease not amenable to surgical resection, or R1 resection post original surgical debulking
- •3. Positive 123I-mIBG diagnostic scan
- •4. Stable blood pressure (<140/90mmHg), if appropriate, on anti-hypertensive therapy
- •5. No previous systemic chemotherapy within 3 months prior to registration
- •6. No previous mIBG therapy within 12 months prior to registration
- •7. Measurable disease (according to RECIST v1.1)
- •8. WHO performance status 0 or 1
- •9. Age = 18 years
- •10. Estimated life expectancy > 3 months
- •11. Adequate bone marrow function:
- •Haemoglobin = 100 g/L
- •WBC = 3.0 x 10^9/L
- •Absolute neutrophil count (ANC) = 1.5 x 10^9/L
- •Platelet count = 100 x 10^9/L
- •12. Adequate liver function:
- •Total bilirubin = 1.5 x upper limit of normal (ULN). This criterion does not apply to patients with Gilbert’s Disease
- •ALT or AST =2.5 x ULN or = 5 x ULN if judged by the investigator to be related to liver metastases
- •ALP =2.5 x ULN or = 5 x ULN if judged by the investigator to be related to liver metastases
- •13. Adequate renal function:
- •Serum urea and serum creatinine < 1.5x ULN AND
- •Calculated creatinine clearance (GFR) =50 mL/min estimated using a validated creatinine clearance calculation (e.g. Cockroft-Gault or Wright formula). If the calculated GFR is below 50, isotope clearance test (Cr51-EDTA or 99mTc-DTPA) is required to confirm GFR = 50 mL/min
- •14. Electrolytes:
- •Potassium = 4.0 mmol/L and = 5.5 mmol/L
- •Magnesium = LLN and = 1.23 mmol/L
- •Corrected calcium within institution normal range
- •15. Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be using adequate contraception, which must be continued for 12 months after completion of treatment (male patients must also agree to use contraception during the trial and for 12 months after last dose of MIBG)
- •16. Patients should be able to swallow oral medication e.g. capsules or tablets
- •17. Capable of giving written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Patients undergoing current treatment with curative intent
- •2. Previous or current malignancies of other histological types within the last 5 years, with the exception of tumours associated with MEN-2a, MEN-2b, VHL and NF1, in-situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin
- •3. Any prior exposure to VEGF, EGFR, or RET inhibitors or history of hypersensitivity to vandetanib, or any excipient agents
- •4. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
- •5. Evidence of active uncontrolled infection (patients on antibiotics are eligible)
- •6. Chronic gastrointestinal disease (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
- •7. Cardiovascular exclusion criteria:
- •Significant cardiac event (myocardial infarction), superior vena cava syndrome, NYHA Class II or above, within 12 weeks before registration, or presence of cardiac disease that in the opinion of the investigator increased the risk of ventricular arrhythmia
- •Prior or current cardiomyopathy
- •Baseline LVEF < 40% as measured by echocardiogram (ECHO)/multiple uptake gated acquisition scan (MUGA)
- •Atrial fibrillation with heart rate > 100 bpm
- •Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled by medication are permitted
- •Unstable ischaemic heart disease (myocardial infarction within 6 months prior to starting treatment, or angina requiring use of nitrates more than once weekly)
- •History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment (CTCAE grade 3)
- •QTcB (QT interval, corrected using Bazett’s formula) prolongation = 480 ms at baseline (Note: If a patient has a QTc interval = 480 ms on screening ECG, the screening ECG may be repeated twice [at least 24 hours apart] for a total of 3 ECGs. The average QTc from the three screening ECGs must be < 480 ms in order for the patient to be eligible for the study)
- •Congenital long QT syndrome or 2nd degree relative with unexplained sudden death under 40 years of age
- •QT prolongation with other medications that required discontinuation of that medication
- •8. Any psychiatric or other disorder likely to impact on informed consent
- •9. Major surgery within 28 days prior to registration
- •10. Brain metastases or spinal cord compression, unless treated at least four weeks before the first vandetanib dose and stable without steroid treatment for 10 days
- •11. Any concomitant medications that may affect QTc or induce CYP3A4 function (with the exception of somatostatin or somatostatin analogue) and/or prohibited medications
- •12. Women who are pregnant or lactating
研究者
相似试验
撤回
1 期
Phase I Trial of Vandetanib Combined With 131I-mIBG to Treat Patients With Advanced Phaeochromocytoma and ParagangliomaPhaeochromocytomaParagangliomaNCT01941849University College, London
已完成
1 期
Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)Diffuse Intrinsic Pontine GliomaNCT00996723St. Jude Children's Research Hospital25
尚未招募
Unknown
Phase 1b/2 trial for venadaparib in combination with paclitaxel and ramucirumab as a second-line therapy for gastric cancer with homologous recombination repair deficiencyNeoplasmsKCT0009067ational Cancer Center75
进行中（未招募）
不适用
Study to determine the activity and safety of vandetanib in children and adolescentsHereditary medullary thyroid cancerMedDRA version: 14.1Level: LLTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004934-32-Outside-EU/EEAational Cancer Institute21
已完成
1 期
Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic CancerAdvanced Malignant NeoplasmMetastatic Malignant NeoplasmRecurrent Malignant NeoplasmRefractory Malignant NeoplasmNCT01582191M.D. Anderson Cancer Center123