Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment

NCT03108209 | Completed

• 1 other identifier: RC2015/PhMZb/Fr/TCO04915
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phototoxicity

Outcome Measures

Primary Outcomes (1)

• Number of photosensitivity reactions as assessed by CTCAE v4.03

  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)

  3 months

Study Arms (1)

single arm

EXPERIMENTAL

Signle arm study. Every subjects apply Photoderm Max lait SPF50+ and Photoderm stick SPF50+

Other: Photoderm Max lait SPF50+; Other: Photoderm Max Stick SPF50+

Interventions

Photoderm Max lait SPF50+ OTHER

Subjects apply Photoderm Max lait SPF50+ at the beginning of their treatment by Vemurafenib/Cobimetinib in prevention of phototoxicities

single arm

Photoderm Max Stick SPF50+ OTHER

Subjects apply Photoderm Max Stick SPF50+ at the beginning of their treatment by Vemurafenib/Cobimetinib in prevention of phototoxicities

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Michele Sayag: lead

Study Sites (1)

CHU Nantes

Nantes, France

Location

MeSH Terms

Conditions

Dermatitis, Phototoxic

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Photosensitivity Disorders; Skin Diseases, Eczematous

Study Officials

• Brigitte Dreno, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: April 11, 2017
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)