A Phase I Study of Intravenously Administered FAU (1-(2'-Deoxy-2'-Fluoro-B-D-arabinofuranosyl) Uracil, NSC#678515) in Patients With Advanced Solid Tumors
I. To assess the safety and tolerability of FAU in patients with advanced solid tumors or
II. To determine the dose-limiting toxicity and maximum tolerated dose (MTD) of FAU in these
I. To observe the clinical response in patients treated with FAU. II. To characterize the
pharmacokinetics of FAU in these patients. III. To explore whether an association exists
between pre-treatment 18F-FAU PET standardized uptake value levels and time to tumor
progression after treatment with unlabeled FAU.
IV. To estimate the protein levels of thymidylate synthase (TS) in archival tumor tissue
samples and to compare them with thymidine kinase (TK) and TS protein levels and TK and TS
mRNA levels in fresh tumor tissue samples from patients treated at the MTD.
V. To explore the relationship between genetic polymorphisms of TS and tumor 18F-FAU uptake.
OUTLINE: This is a multicenter study.
Patients receive FAU IV over 1 hour on days 1-5. Courses repeat every 28 days in the absence
of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed for 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose, defined as the dose at which no more than 1/6 patients develops dose-limiting toxicity, graded by NCI CTCAE version 4.0
Up to 28 days
Wayne State University
United States: Food and Drug Administration
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