Phase III Study of GSK1120212 in BRAF V600E/K positive melanoma

• Research type

  Research Study

• Full title

  MEK114267, A Phase III randomized, open-label study comparing GSK1120212 to chemotherapy in subjects with advanced or metastatic BRAF V600E/K mutation-positive melanoma

• IRAS ID

  68630

• Sponsor organisation

  GlaxoSmithKline Research and Development Limited

• Eudract number

  2010-022838-85

• Clinicaltrials.gov Identifier

  01245062

• Research summary

  GSK1120212 is a new oral inhibitor of "MEK", an important molecule that can stimulate the growth of cancer cells. GSK1120212 has been shown to inhibit the growth and reproduction of melanoma skin cancer cells, which have a mutation in the "BRAF oncogene". Melanoma is an aggressive skin cancer, which is difficult to treat effectively once it has spread to other sites in the body. It kills >90% of sufferers with advanced disease within 5 years. This study compares the available current, intravenous treatments (dacarbazine or paclitaxel) with the new agent, GSK1120212, in patients with advanced melanoma. The study will be conducted in a sub-group of patients whose tumour carries a genetic mutation referred to as, "the BRAF V600E/K mutation". These patients represent about 40% of the total population of patients with melanoma. It is in this population that GSK1120212 is thought to be most effective. To select patients for the study, tissue from the tumour will be used for genetic analysis to identify the presence of the V600E mutation. The study includes both 1st and 2nd line patients, conducted on an open, multicentre, international basis. Patients will be randomly allocated to treatment in a 2:1 fashion; 198 subjects will receive the new treatment (2mg once daily) and 99 subjects will receive the comparative treatment (dacarbazine 1000mg/m2 (first-line patients) or paclitaxel 175mg/m2 (second-line patients)intravenously. Treatment will continue until disease progression, unacceptable toxicity or withdrawal. The primary measure of effectiveness of the treatment will be progression free survival, as assessed by the investigator. Patients randomised to intravenous chemotherapy, the control arm of the study, will be invited to crossover to treatment with GSK11202212, if they have shown disease progression, based upon Standard radiological criteria (RECISTv1.1).

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  10/H0301/64

• Date of REC Opinion

  3 Feb 2011

• REC opinion

  Further Information Favourable Opinion