Selumetinib therapy in patients with metastatic uveal melanoma.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily.
Research Site
Los Angeles, California, United States
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1.
Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR
ORR at Week 6 using BICR according to RECIST 1.1
Time frame: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR
Percent change in tumour size at Week 6 using BICR according to RECIST 1.1
Time frame: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015
Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine
Overall Survival
Time frame: From Randomization, up until death assessed up to 15th May 2015
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Research Site
Aurora, Colorado, United States
Research Site
Atlanta, Georgia, United States
Research Site
Lutherville, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Edegem, Belgium
Research Site
Ghent, Belgium
Research Site
Kortrijk, Belgium
...and 21 more locations