A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor
I. To determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of
SJG-136 in patients with an advanced solid tumor.
I. To determine preliminary efficacy data and evaluation of correlative markers of DNA
damage and apoptosis in peripheral blood lymphocytes.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive SJG-136 intravenously (IV) over 20 minutes on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 patients receive escalating doses of SJG-136 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. At least 6 patients are treated at the MTD.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase 2 dose of SJG-136
Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|