Expanded Access Study in patients with Metastatic Melanoma

• Research type

  Research Study

• Full title

  An open-label, multicentre expanded access study of RO5185426 in patients with metastatic melanoma

• IRAS ID

  73532

• Sponsor organisation

  Optum

• Eudract number

  2010-023526-21

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The incidence of melanoma (most serious form of skin cancer) is increasing worldwide, and metastatic (cancer cells that have spread beyond the original tumour site) melanoma represents a major clinical challenge as it is an essentially incurable disease with few satisfactory treatment options and the outcome of metastatic melanoma remains poor with an average survival time of only 6-9 months from the diagnosis of distant metastases. After failure of first line treatment response rates to any therapy have been very poor and, to date, no effective second line treatment has been established and the preferred option for patients with metastatic disease is still enrollment into clinical trials. This is an open-label, multicentre, expanded access study to make RO5185426 available to larger number of metastatic melanoma patients, approximately 900 patients across 140 centres in 30 countries, than could otherwise be treated in trials and who are without satisfactory treatment options. The primary objective of this study will be to evaluate the safety of RO5185426 in patients with metastatic melanoma who have the V600 BRAF mutation (a change in one of the genes that leads to melanoma cancer cells), and a secondary objective is to evaluate how effective RO5185426 is at reducing the size of the tumours.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0073

• Date of REC Opinion

  4 May 2011

• REC opinion

  Further Information Favourable Opinion