A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors
This is an open-label phase I, dose-escalation safety study in subjects with refractory
solid tumors. The primary objectives of the study are to assess the safety, tolerability,
and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous
infusion on days 1, 8 and 15 of each 28 day cycle. The planned minimum treatment schedule is
2 cycles (8 weeks) of PG-11047 treatment. Subjects who tolerate treatment may be eligible to
receive additional cycles as per investigator's medical judgment. Evaluation of anti-tumor
response will be performed every 2 cycles.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT). Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047.
The MTD had to occur during cycle 1 of treatment
Mark Ratain, M.D.
University of Chicago
United States: Food and Drug Administration
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