ISRCTN75715723已完成未知
Topical tropomysin kinase (TRK) inhibitor as a treatment for inherited CYLD-defective skin tumours (TRAC)
ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 28 人开始时间: 2014年10月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28270164 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29955768
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females age 18 years and older
- •2. Patients from genotyped pedigrees with known CYLD mutations; or if they have a clinical phenotype compatible with this diagnosis
- •3. Patients that are suitable for the trial will have at least one eligible tumour
- •4. The eligible tumour will be scheduled for removal >4 weeks from consent
- •5. The eligible tumour must be no more than 3cm in size
- •6. For women of childbearing age: a negative pregnancy test is required prior to study entry, and on completion of trial treatment. The patient must be using an adequate contraception method and agree to continue using this throughout the trial and for at least 2 weeks after stopping trial medication
- •7. Sexually active men must agree to use barrier forms of contraception
- •8. The recruiting clinician must be confident that the patient understands the consent process and has the capacity and willingness to provide fully informed consent for participation in the trial
- •1. Males and females age 18 years and older
- •2. For women of child bearing age: a negative pregnancy test is required prior to study entry, and on completion of trial treatment. The patient must be using an adequate contraception method and agree to continue using this throughout the trial and for at least 2 weeks after stopping trial medication
- •3. Patients from genotyped pedigrees with known CYLD mutations, or if they have a clinical phenotype compatible with this diagnosis
- •4. Patients will optimally have 8-10 eligible tumours
- •5. Eligible tumours will be less than 1 cm in diameter and no more than 2 cm in diameter at the base
- •6. Eligible tumours must be spaced at least 1 cm apart from other eligible tumours to avoid crosscontamination
- •7. The recruiting clinician must be confident that the patient understands the consent process and has the capacity and willingness to provide fully informed consent for participation in the trial
- •8. Patients who have completed Phase 1b without adverse reaction and after completing a minimum 2 week treatment free washout period
排除标准
- •1. Patients aged <18 years
- •2. Patients without CYLD defective tumours
- •3. CYLD defective tumours which are ulcerated (these tumours will be managed according to standard practice of care)
- •4. The eligible tumour is due to be removed <4 weeks from consent
- •5. Pregnancy or lactation
- •6. Women of childbearing age and sexually active men whom do not wish to use contraception whilst on the study
- •7. Severe incapacity of higher function such that fully informed consent cannot be achieved, to be determined by clinical judgement
- •8. Use of any other topically administered treatments at the treatment site
- •1. Patients aged <18 years
- •2. Patients without multiple CYLD defective tumours
- •3. Pregnancy or lactation
- •4. Women of childbearing age and sexually active men whom do not wish to use contraception whilst on the study
- •5. CYLD defective tumours which are ulcerated, have recently changed or are painful (these tumours will be managed according to standard practice of care)
- •6. Severe incapacity of higher function such that fully informed consent cannot be achieved, to be determined by clinical judgement
- •7. Significant concurrent illness
- •8. Patients who developed an adverse reaction to CT327 in cohort 1(score of 4 or above on the modified Draize score)
- •9. Patients who have taken part in cohort 1and not completed a minimum 2 week treatment free washout period
- •10. Large tumours >2cm base diameter will not be eligible
- •11. Any tumour within 10cm of an excision scar of a cohort 1 treated site will not be eligible
- •12. Use of any other topically administered treatments at the treatment site
研究者
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