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Report for Clinical Trial NCT02052193

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study

The BRAF inhibitors dabrafenib and vemurafenib belong both two a new class of potent anti-cancer drugs and are highly efficacious in tumors harboring the BRAF V600E mutation. Both drugs seem to be equally efficacious; however, their toxicity profile seems to differ. Serious phototoxicity has been observed in ~ 30% of patients treated with vemurafenib and in ~2 percent of patients treated with dabrafenib. These phototoxic reactions have developed in spite of informing the patients of this possible adverse event and instructing them to protect themselves. Manifestation of phototoxic reactions depends on the patient's habits of exposure and their efforts to protect themselves. The true frequency of photosensitivity can only be established by systematic photo-testing. In dermatology, standard test procedures with different UV-wavelengths and dosages have been established and the primary goal of this study will be to clarify the true rate of photosensitivity by these two BRAF-inhibitors. Furthermore, systematic experience will be collected how to best protect patients from phototoxic events. Dabrafenib and Vemurafenib are commercially available and considered standard of care for BRAF mutant metastatic melanoma in Germany. As the number of patients will not allow any conclusion with regard to efficacy or safety of vemurafenib, patients randomized to vemurafenib in part 2 will only remain on study until completion of phototesting.

NCT02052193 Metastatic Melanoma (Carrying BRAF V600 Mutation)
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

2 Interventions

Name: Dabrafenib

Description: Measurement of toxicity related to UV exposure
Type: Drug
Group Labels: 2

Dabrafenib Vemurafenib

Name: Vemurafenib

Description: Measurement of toxicity related to UV exposure
Type: Drug
Group Labels: 2

Dabrafenib Vemurafenib


Primary Outcomes

Measure: Degree of Solar Dermatitis due to Standardized UV Exposure in Patients treated with Dabrafenib

Time: day 2-5

Measure: Degree of Solar Dermatitis due to Standardized UV Exposure in Patients treated with Dabrafenib or Vemurafenib

Time: day 2-5

Secondary Outcomes

Measure: Number of Participants with Adverse Events treated with dabrafenib

Time: day 1-28

Measure: Best overall response rates and progression free survival in patients treated with dabrafenib or vemurafenib using RECIST v1.1 criteria

Time: Every 3 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study The BRAF inhibitors dabrafenib and vemurafenib belong both two a new class of potent anti-cancer drugs and are highly efficacious in tumors harboring the BRAF V600E mutation. --- V600E ---



HPO Nodes


HPO: