A Phase I Dose Escalation Study of Daily x 3 Intravenous SJG-136 in Patients With Advanced Solid Tumors
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetic parameters of this drug and its metabolites in these
patients.
II. Correlate pharmacokinetic parameters with clinical effects of this drug in these
patients.
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.
Interventional
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
21 days
Yes
Igor Puzanov
Principal Investigator
Vanderbilt University
United States: Food and Drug Administration
NCI-2009-00085
NCT00121290
February 2005
Name | Location |
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Vanderbilt University | Nashville, Tennessee 37232-6305 |