Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors
- Determine the maximum tolerated dose of therapeutic angiotensin-(1-7) in patients with
metastatic or unresectable solid tumors.
- Determine the pharmacokinetics of this drug in these patients.
- Determine tumor response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive therapeutic angiotensin-(1-7) subcutaneously on days 1-5. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of therapeutic angiotensin-(1-7) 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 during the first 3 weeks
of study therapy. At least 6 patients are treated at the MTD.
Blood samples are collected from patients after the first and fifth doses of the study drug
for pharmacokinetic correlative studies.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
W. Jeffrey Petty, MD
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|