UKMCC-01, Version 1.0, 01-Jun-2012

• Research type

  Research Study

• Full title

  A Phase II Study of Pazopanib in Metastatic Merkel Cell Carcinoma

• IRAS ID

  85295

• Contact name

  Paul Nathan

• Sponsor organisation

  University of Birmingham

• Eudract number

  2011-003226-27

• Research summary

  Merkel cell carcinoma (MCC) is a rare type of skin cancer. There are approximately 400 new patients diagnosed per year in the UK. Chemotherapy is often used to treat people with MCC if the disease has spread and cannot be removed by surgery (advanced disease). Chemotherapy often shrinks MCC but unfortunately the disease usually comes back. There have been few trials of new drugs in advanced MCC because of the rarity of the disease. Pazopanib (a multi-targeted tyrosine kinase inhibitor) is used for the treatment of advanced renal cell carcinoma. There is some evidence to suggest it may also work in advanced MCC. UKMCC-01 is a non-randomised, phase II study of pazopanib for patients with advanced MCC who are fit enough to receive treatment. A maximum of 25 patients will be recruited from approx 12 UK centres. The aim is to determine whether there is sufficient response to pazopanib to warrant conducting a large, randomised phase III trial. A tissue bank will be established to allow scientists to study blood and tumour samples from people with MCC in order to understand how this rare cancer works, which will help researchers develop new treatments. All patients taking part in the trial will need to have a Computerised Tomography (CT) scan and a heart trace (ECG) before they begin treatment. Patients will be asked to take 4 200mg pazopanib tablets once per day every day. Repeat CT scans will be performed at 6 weeks and then every 8 weeks. ECGs will be repeated after 8 weeks of treatment and then every 8 weeks. Blood and tumour samples will also be collected. UKMCC-01 is a non-commercial clinical trial, sponsored by the University of Birmingham, and funded by Cancer Research UK and GlaxoSmithKline (also providing pazopanib free of charge).

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0514

• Date of REC Opinion

  2 Nov 2012

• REC opinion

  Further Information Favourable Opinion