This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
New Brunswick, New Jersey, United States
Unnamed facility
Charlotte, North Carolina, United States
Unnamed facility
Houston, Texas, United States
AEs, laboratory parameters.
Time frame: Throughout study
Pharmacokinetic and pharmacodynamic profiles of R547
Time frame: Throughout study
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