I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LE-SN38.
II. Determine the plasma pharmacokinetics of SN38 following IV administration of LE-SN38.
III. Observe any anti-tumor effects of LE-SN38.
This is an open-label study in patients with advanced solid tumors who have failed
LE-SN38 will be administered IV over 90 minutes. At least three patients will be studied at
each dose level and at least three patients will complete one 21-day course before any
patient is enrolled at the next dose level. Study drug administration will continue on an
every 21-day schedule in the absence of progressive disease or unacceptable toxicity. A
subsequent course of treatment may be administered at least 21 days after receiving a prior
dose of LE-SN38 when study criteria are met.
Cohorts of 3 patients per dose level will be studied. This will be expanded to 6 if a DLT
occurs, followed by a total of 6 patients at a possible MTD.
Disease status will be assessed after every second cycle. In the event of disease
progression, study treatment will be discontinued and all end of treatment study evaluations
will be performed.
PROJECTED ACCRUAL: Up to 40 patients will be enrolled.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mayer Fishman, MD, PhD
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|The Ohio State University||Columbus, Ohio 43210|