Ignite Creation Date:
2024-05-06 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03108209
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2017-03-14
Brief Title:
Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment
Sponsor:
Michele Sayag
Organization:
NAOS Institute of Life Science
Study Overview
Official Title:
Evaluation of the Interest and Tolerance of a Photoprotection Strategy in Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment Associated or Not With Cobimetinib
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 110 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
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 110 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
Detailed Description:
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 110 according to MedDRA
Two studies on Vemurafenib as monotherapy have demonstrated these results One study concerns 468 patients from a randomized open-label Phase III study in adult patients with non-resectable melanoma or stage IV with a BRAF V600 mutation the other is a study Phase II study in a single group of patients with stage IV melanoma carrying a BRAF V600 mutation after failure of at least one prior systemic treatment The study on the combination of Vemurafenib and Cobimetinib is a randomized double-blind placebo-controlled phase III study GO28141 which evaluated Cobimetinib in combination with vemurafenib compared to vemurafenib alone Of patients with non-resectable stage III or metastatic stage IV melanoma carrying a BRAF V600 mutation naive from any treatment
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
The objective of the study is to demonstrate that the application of Photoderm Max SPF50 Milk UVA UVB broad spectrum sunscreen associated with the application of the Photoderm Max SPF50 stick SPF 50 on the first day of treatment with Vemurafenib or its combination with cobimetinib reduces the occurrence of this adverse event from a frequency 110 to a frequency 110 with regular application to all exposed areas
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 110 according to MedDRA
Two studies on Vemurafenib as monotherapy have demonstrated these results One study concerns 468 patients from a randomized open-label Phase III study in adult patients with non-resectable melanoma or stage IV with a BRAF V600 mutation the other is a study Phase II study in a single group of patients with stage IV melanoma carrying a BRAF V600 mutation after failure of at least one prior systemic treatment The study on the combination of Vemurafenib and Cobimetinib is a randomized double-blind placebo-controlled phase III study GO28141 which evaluated Cobimetinib in combination with vemurafenib compared to vemurafenib alone Of patients with non-resectable stage III or metastatic stage IV melanoma carrying a BRAF V600 mutation naive from any treatment
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
The objective of the study is to demonstrate that the application of Photoderm Max SPF50 Milk UVA UVB broad spectrum sunscreen associated with the application of the Photoderm Max SPF50 stick SPF 50 on the first day of treatment with Vemurafenib or its combination with cobimetinib reduces the occurrence of this adverse event from a frequency 110 to a frequency 110 with regular application to all exposed areas
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None