A study conducted in many hospitals, carried out in two groups of patients with advanced skin cancer who know that they are receiving the study medication and have previously received treatment for th...

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-019526-14

A study conducted in many hospitals, carried out in two groups of patients with advanced skin cancer who know that they are receiving the study medication and have previously received treatment for their advanced skin cancer and the disease has progressed since that treatment

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Extrait

The primary objectives of this study are: • To assess the ORR (complete response + partial response [CR + PR]) of E7080 in subjects with unresectable stage III or stage IV melanoma not harboring the V600E BRAF mutation and disease progression following first-line standard of care therapy (Cohort 1). • To assess the ORR of E7080 in subjects with unresectable stage III or stage IV melanoma harboring the V600E BRAF mutation and disease progression following BRAF-V600E-targeted therapy (Cohort 2).


Critère d'inclusion

  • American Joint Committee on Cancer unresectable stage III or stage IV melanima and disease progression with subjects not harboring the V600E-BRAF mutation with disease progression following first line standard of care (cohort 1) or subjects harboring the V600E-BRAF mutation with disease progression following BRAF-V600E-targeted therapy (cohort 2)