EUCTR2016-005104-25-GB进行中（未招募）1 期
Relative bioavailability and comparative pharmacokinetics of 13-CRA oral liquid and extracted capsule formulations: a randomised, open label, multi-dose, cross-over clinical trial in patients requiring treatment cycles of 13-CRA. - My-CRA, Liquid 13 Cis Retinoic Acid
ova BioPharma Limited0 个研究点目标入组 20 人开始时间: 2017年11月6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
- 20
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
- •To be eligible for inclusion into this trial the patients must fulfil all of the following criteria:
- •1.Male or female aged from 0 years to < 21 years of age.
- •2.Patient with high risk neuroblastoma, or unresectable, unfavourable histology intermediate risk neuroblastoma the latter age = 18 months at diagnosis
- •3.Patient who is scheduled to receive at least two treatment cycles of 13-CRA.
- •4.Patient who cannot swallow 13-CRA capsules (i.e. requires extraction of 13-CRA from the capsules).
- •5.Negative pregnancy test for females of child-bearing potential before initiation of treatment, and sexually active patients and partners agreeing to undertake adequate contraceptive measures (see section 4.5).
- •6.Provision of a single or double lumen central venous catheter for sampling (i.e. already in place).
- •7.Parent(s)/legal guardian able and willing to provide written informed consent for the patient to take part in the trial.
- •8.Where applicable, the patient should assent to undergo blood sampling for pharmacokinetic purposes and to allow physiological measurements to be made.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •To be eligible for inclusion in this trial the patients must not meet any of the following criteria:
- •1.Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the trial.
- •2.Diagnosis of high-risk neuroblastoma (HRNBL) which is currently being treated on the SIOPEN HRNBL trial (children who have exited this trial will be eligible).
- •3.Known allergy to 13-CRA or any of the excipients.
- •4.Inadequate contraception measures in females of childbearing age.
- •5.Receiving concomitant treatment with tetracyclines.
- •CRITERIA PRIOR TO STARTING EACH CYCLE OF 13-CRA
- •1.Total bilirubin = 1.5 x normal, and (SGPT) ALT = 5 x normal. Veno-occlusive disease if present, should be stable or improving.
- •2.Skin toxicity no greater than CTCAE Grade 1(10)
- •3.Serum triglycerides <5.65mmol/L.
- •4.No haematuria and / or proteinuria on urinalysis.
- •5.Serum calcium = 2.9mmol/L.
- •6.Serum creatinine based on age / gender as follows:
- •AgeMaximum Serum Creatinine µmol/L
- •1 month to < 6 months3535
- •6 months to < 1 year4444
- •1 to < 2 years 5353
- •2 to < 6 years 7070
- •6 to < 10 years 8888
- •10 to < 13 years 106106
- •13 to < 16 years 132124
- •= 16 years 150124
- •7.Patients with a seizure disorder must be well controlled and taking anticonvulsants. CNS toxicity < grade 2 (CTCAE).
- •WITHDRAWAL CRITERIA
- •1.Positive pregnancy test - pregnancy testing will be undertaken before treatment commences and routinely before each course of treatment in females of child-bearing potential. If a patient is found to be pregnant during the trial, the next course of treatment will not be given until the pregnancy has been discussed with the treating clinician, and the patient will be withdrawn from the trial whether or not treatment is continued.
- •2.Request of the patient, for any reason.
- •3.Discretion of the investigator.
研究者
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