The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
239
Oral liquid or Capsule
oral
Research Site
Santa Monica, California, United States
To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS)
Time frame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Time to death
Time frame: From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
Objective Response Rate
Time frame: RECIST data collected as per institutional standard practise
Duration of response
Time frame: RECIST data collected as per institutional standard practise
Assessment of the safety and tolerability of AZD6244
Time frame: Assessed at all visits
Investigation of the pharmacokinetics of AZD6244
Time frame: Day 1 & 8 (for patients on AZD6244)
Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive
Time frame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
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Research Site
Aurora, Colorado, United States
Research Site
Miami Beach, Florida, United States
Research Site
Niles, Illinois, United States
Research Site
Boston, Massachusetts, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
...and 23 more locations