Evaluation of the Interest and Tolerance of a Photoprotection Strategy in Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment Associated or Not With Cobimetinib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of photosensitivity reactions as assessed by CTCAE v4.03
研究概览
简要总结
Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.
Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.
These treatments are associated with a lot of adverse reactions, which may lead to dose reduction, temporary interruption or discontinuation of treatment, which often leads to treatment failure or a decrease in treatment compliance.
The most commonly reported adverse reactions (> 30%) with Vemurafenib are arthralgia, rash, photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse events (> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia, photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate aminotransferase, blood creatine phosphokinase elevation and vomiting.
The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in combination with Cobimetinib is very common (≥ 1/10) according to MedDRA.
The use of optimal photoprotection including the repeated daily use of external photoprotection products is currently recommended for all patients receiving treatment with vemurafenib or with the combination of vemurafenib and cobimetinib.
详细描述
Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.
Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.
These treatments are associated with a lot of adverse reactions, which may lead to dose reduction, temporary interruption or discontinuation of treatment, which often leads to treatment failure or a decrease in treatment compliance.
The most commonly reported adverse reactions (> 30%) with Vemurafenib are arthralgia, rash, photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse events (> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia, photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate aminotransferase, blood creatine phosphokinase elevation and vomiting.
The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in combination with Cobimetinib is very common (≥ 1/10) according to MedDRA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject naive of i-BRAF treatment, receiving a Vemurafenib treatment in association or not with Cobimetinib in 1st or 2nd line of treatment in non resecable metastatic melonoma with BRAF V600 mutation;
- •Subject aged 18 or older ;
- •Subject who can be follow regularly by the investigator ;
- •Informed and consent subjects who read and signed the ICF ;
- •Subject who does not participate in another study, exepted therapeutic clinical trial with Vemurafenib in association or not with Cobimetinib ;
- •Compliant subject, left to the discretion of the investigator.
排除标准
- •Pregnant or lactating women
- •Women of reproductive age without contraception deemed effective for at least 1 month
- •For women of reproductive age receiving Cobimetinib treatment, lack of use of two effective methods of contraception, such as a condom or other barrier method (with spermicide if available).
- •Subject having a history of allergy to an ingredient of the tested products
- •Subject with skin sensitivity to sunscreens or any of the components of the products under investigation
- •Subjects taking another photosensitising treatment (left to the discretion of the investigator)
- •Subject presenting a concomitant pathology which may interfere with the course of the study (left to the discretion of the investigator)
- •Subjects with cutaneous photosensitivity or systemic disease including: lupus, dermatomyositis, porphyria, lucite ... (non-exhaustive list left to the discretion of the investigator).
研究组 & 干预措施
single arm
Signle arm study. Every subjects apply Photoderm Max lait SPF50+ and Photoderm stick SPF50+
干预措施: Photoderm Max lait SPF50+ (Other)
single arm
Signle arm study. Every subjects apply Photoderm Max lait SPF50+ and Photoderm stick SPF50+
干预措施: Photoderm Max Stick SPF50+ (Other)
结局指标
主要结局
Number of photosensitivity reactions as assessed by CTCAE v4.03
时间窗: 3 months
Decrease of photosensitivity reaction frequency (in total number of reaction) compared to what is described in the Summary of Product Characteristics of Vemurafenib (photosensitivity reactions are described as very common ≥ 1/10)
次要结局
未报告次要终点
研究者
Michele Sayag
Dr
NAOS Institute of Life Science