A Phase I Dose Escalation Study of Daily x 3 Intravenous SJG-136 in Patients With Advanced Solid Tumors
I. Determine the maximum tolerated dose and recommended phase II dose of SJG-136 in patients
with metastatic or unresectable solid tumors.
II. Determine the safety and dose-limiting toxic effects of this drug in these patients.
III. Determine, preliminarily, the efficacy of this drug in these patients.
I. Determine the pharmacokinetic parameters of this drug and its metabolites in these
II. Correlate pharmacokinetic parameters with clinical effects of this drug in these
OUTLINE: This is an open-label, dose-escalation study.
Patients receive SJG-136 IV over 20 minutes once daily on days 1-3. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 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.
After completion of study treatment, patients are followed for 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
United States: Food and Drug Administration
|Vanderbilt University||Nashville, Tennessee 37232-6305|