EUCTR2010-022439-12-BE进行中（未招募）1 期
A Phase II Placebo Controlled, Multicenter Study to Investigate the Safety and Efficacy of ATH008 cream in Patients with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy.
Advancell Advanced In Vitro Cell Technologies, S.A0 个研究点目标入组 114 人开始时间: 2010年11月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
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
- •Have signed Informed Consent.
- •Are under capecitabine therapy for treatment of colon or breast cancer at a regimen of 2 weeks on and 1 week off (14+7) and a daily doses between 2000 and 2500 mg/m2.
- •Diagnosis of PPES grade 1 in any hand or foot according to the NCI CTCAE v4.03 definition.
- •Are able to apply topical medication or provide for another person to apply it.
- •Have a life expectancy longer than 3 months.
- •In Part I, subjects still have to undergo at least 1 planned cycle with capecitabine therapy.
- •In Part II, subjects still have to undergo at least 2 planned cycles with capecitabine therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Are younger than 18 years.
- •Have neurologic symptoms greater than grade 1, which under the criteria of the clinician could interfere with PPES diagnosis or study treatment (e.g. hands or feet neuropathy).
- •Diagnosis of PPES grade 1 in any hand or foot according to the NCI CTCAE v4.03 definition (Appendix 20.1) for more than 2 cycles previously to inclusion in this clinical study.
- •Have any dermatologic condition that in the opinion of the investigator may affect hands or feet or may complicate evaluation during study treatment (e.g. neurodermatitis, psoriasis, etc).
- •Use of other chemotherapies for the treatment of cancer except trastuzumab (Herceptin ®) or bevacizumab (Avastin ®)
- •Have onycholysis with a non-stable grade 1 or onycholysis greater than grade 1 (nail loss, NCI CTCAE v4.03 criteria) which in the assessment of the clinician could interfere with PPES diagnosis or treatment.
- •Need to use other emollient creams or other topical treatments in hands and/or feet during the study.
- •Are receiving radiotherapy.
- •Are actively treated with systemic allopurinol (oral or parenteral) for the treatment of gout, or any other indication.
- •Have developed a severe reaction to allopurinol in the past (e.g. Lyell syndrome).
- •Known allergy to allopurinol or any of the excipients of the product.
- •Previous contraindication to treatment with capecitabine.
- •Have received topical corticosteroids in hands and/ or feet 7 days prior to planned inclusion in the study.
- •Are participating in any other investigational studies for the treatment of PPES.
- •Have participated in any other investigational studies for the treatment of PPES, or received an experimental therapeutic procedure, considered to potentially interfere with the study in the 4 weeks preceding Day 1.
- •Have a serious medical or psychiatric condition that could, in the investigator’s opinion, potentially interfere with their study treatment or participation in the study.
- •Pregnant women, women in child bearing age not using contraceptives or men not using contraceptives. Methods of contraception which have a failure rate (Pearl index) of less than 1% per year are regarded as highly effective.
- •Are participating in other clinical trials.
- •Haematological limits indicating that capecitabine (Xeloda®) cannot be administered due to safety reasons, based on the PI review before each cycle of chemotherapy.
- •Total bilirubin > 3 upper normal value.
- •Serum creatinine level > 2 upper normal value.
研究者
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