A Phase I Trial of Sarcosinamide Nitrosourea (SarCNU) in Patients With Solid Tumors
I. Determine the maximum tolerated dose (MTD) of an oral formulation of SarCNU given on an
every 4th day times three schedule (days 1, 5, 9).
II. Establish an appropriate oral dose of SarCNU for phase II clinical trials. III. Identify
the dose-limiting toxicities (DLTs) of SarCNU. IV. Determine the oral bioavailability of
SarCNU. V. Characterize the plasma pharmacokinetics of SarCNU.
I. Determine whether SarCNU undergoes metabolic N-demethylation to generate reactive
isocyanate species that have been implicated in BCNU pulmonary toxicity.
II. Evaluate response to treatment with SarCNU in patients with measurable or evaluable
III. Attempt to establish pharmacodynamic relationships for response and/or toxicity.
OUTLINE: This is a dose-escalation study.
Patients receive oral sarcosinamide nitrosourea (SarCNU) on days 1, 5, and 9. Treatment
continues every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SarCNU until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
Patients are followed at 4-5 weeks posttreatment.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dana-Farber Cancer Institute
United States: Food and Drug Administration
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