AZD6244 in combination with dacarbazine in advanced melanoma

• Research type

  Research Study

• Full title

  A Phase II, double blind, randomised study to assess the efficacy of AZD6244 (hyd-sulfate) in combination with dacarbazine compared with dacarbazine alone in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

• IRAS ID

  11059

• Contact name

  Mark Middleton

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2008-006344-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Melanoma is the most clinically significant, potentially life-threatening form of skin cancer and the incidence has been increasing over recent decades. Although there have been improvements in the prevention, diagnosis and treatment of patients with melanoma, there are still more than 1500 deaths in the UK each year.Standard treatment for patients with advanced melanoma has not been defined since existing treatments have not shown significant improvements in overall survival of patients. Dacarbazine is often used as a standard of care for patients with advanced melanoma, although responses tend to be infrequent and short in duration. This study will test whether a new drug, AZD6244, in combination with dacarbazine will improve overall survival of patients with advanced melanoma, whose tumours have BRAF mutations. BRAF mutations occur in approximately 60% of patients with cutaneous melanoma and activate an intracellular pathway (known as the MAPK pathway), leading to uncontrolled cell proliferation. AZD6244 inhibits an enzyme (MEK) in this intracellular pathway and reduces its activity, which may offer potential therapeutic benefit in patients with such mutations. Earlier studies with AZD6244, when used alone in patients with advanced melanoma and some other cancer types, have demonstrated signs of anti-tumour activity. AZD6244 will now be tested in combination with standard chemotherapy.Patients with advanced melanoma, who have been tested to see if their tumour has BRAF mutation, may be eligible for inclusion in this study. The study is being conducted at specialist cancer centres in the UK (and internationally). Patients will be randomised to receive AZD6244 or placebo in combination with dacarbazine. During the study, patients will be seen frequently at clinic visits and will undergo tests (e.g. MRI/CT scans, blood tests, eye tests, heart tests and questionnaires) to monitor the disease and safety of the study treatment. A pharmaceutical company, AstraZeneca, sponsors the study.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/27

• Date of REC Opinion

  2 Jul 2009

• REC opinion

  Further Information Favourable Opinion