AZ D1344C00001 (SUMIT) Uveal Melanoma
Research type
Research Study
Full title
A Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib (AZD6244, Hyd-Sulfate) in Combination with Dacarbazine Compared with Placebo in Combination with Dacarbazine as First Systemic Therapy in Patients with Metastatic Uveal Melanoma (SUMIT)
IRAS ID
141208
Contact name
Paul D Nathan
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2013-003545-41
Clinicaltrials.gov Identifier
Research summary
This is an international phase III study for patients 18 years old and over with metastatic uveal melanoma (cancer of the eye) who have not received prior systemic therapy (treatment using substances that travel through the bloodstream such as chemotherapy).
Eligible participants will be randomly placed into 1 of 2 groups; one group will received Selumetinib (study drug - tablet) in combination with the standard treatment Dacarbazine (chemotherapy drug) and the other will receive a placebo (physically identical tablet but containing no medication) in combination with Dacarbazine to see how effective the study drug is when used with chemotherapy. This will be measured in terms of the length of time, during and after the treatment that the participant lives with their disease but it does not get worse (progression free survival). Participants will be in the main study until objective disease progression, unable to tolerate the drug or the occurrence of other discontinuation criteria.
Following the main study and confirmation of objective disease progression, participants who are eligible may enter the open-label extension phase where they will receive the study drug as either a stand-alone treatment or in combination with chemotherapy as post-progression therapy if; in the opinion of the Investigator, the participant would derive clinical benefit; there are no significant toxicity concerns and it does not contravene local practice. Participants may continue on post-progression therapy until they meet a criteria for discontinuation.
After the final follow-up visit, participants are to be followed up for their survival status every 8 weeks until they withdraw their consent, the end of the study or their death (whichever occurs first).
Approximately 128 participants are expected to participate in the study globally.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/0113
Date of REC Opinion
12 Feb 2014
REC opinion
Favourable Opinion