Paclitaxel +/- GSK1120212 in Melanoma

• Research type

  Research Study

• Full title

  A randomised phase 2 study of paclitaxel with or without GSK1120212 in advanced wt BRAF melanoma

• IRAS ID

  87684

• Contact name

  Mark Middleton

• Eudract number

  2011-002545-35

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a randomised multi-centre study. 80 patients (forty in each of 2 arms) with melanoma will be randomly assigned to receive treatment with paclitaxel chemotherapy or the same drug along with GSK1120212, a new medicine. To take part the patient's melanoma must have a normal BRAF gene (at V600), which is about 60% of people with melanoma. This can be checked on a sample of the patient's tumour (usually one that has already been taken as part of their treatment). Prior to the randomised part of the study, between 9 and 18 patients will take part in the trial to establish the best dose of GSK1120212 and paclitaxel in combination.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0458

• Date of REC Opinion

  23 Jan 2012

• REC opinion

  Further Information Favourable Opinion