A Phase I Trial of Sarcosinamide Nitrosourea (SarCNU) in Patients With Solid Tumors
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
disease.
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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD
28 days
Yes
Joseph Eder
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
NCI-2013-00028
NCT00004079
August 1999
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |