NCT00471562

Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors

Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of angiotensin-(1-7) in treating patients with metastatic or unresectable solid tumors.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic angiotensin-(1-7)	sequentially increasing doses 50-1000 mcg/kg

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-05-10
• Last updated: 2017-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study