Extrait

The primary objective of the study is to assess the overall intracranial response rate (OIRR), defined as the proportion of subjects with confirmed complete intracranial responses (CRs) or partial intracranial responses (PRs) assessed by investigators in each of two cohorts of subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain treated with oral GSK2118436: • Cohort A: Subjects who have not received any local therapy for brain metastases • Cohort B: Subjects who have failed prior local therapy for brain metastases including but not restricted to brain surgery, Whole Brain Radiotherapy (WBRT) or Stereotactic Radiosurgery (SRS e.g. gamma knife, linear-accelerated-based radiosurgery, charged particles, and CyberKnife).

Critère d'inclusion

• BRAF V600E or V600K mutation-positive metastatic melanoma to the brain

Liens

• ictrp
• euctr
• ictrp
• euctr