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Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment

NCT03108209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-22

No results posted yet for this study

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

Interventions

OTHER

Photoderm Max lait SPF50+

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

OTHER

Photoderm Max Stick SPF50+

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

Sponsors & Collaborators

  • Michele Sayag

    lead INDUSTRY

Principal Investigators

  • Brigitte Dreno, MD · Nantes University Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03108209 on ClinicalTrials.gov