NCT00385177

Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors

A Multicenter Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Achieve Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion, and to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion. Additionally, evaluation of side effects as a function of dose, and observation of any anti-tumor effects of SN2310 Injectable Emulsion will be made.

Detailed description

This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies who have failed conventional therapy. SN2310 Injectable Emulsion will be administered intravenously every 21 days. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion; to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion; to evaluate side effects as a function of dose level; and, to observe any anti-tumor effects of SN2310 Injectable Emulsion.

Conditions

• Breast Neoplasms
• Colorectal Neoplasms
• Pancreatic Neoplasms
• Pelvic Neoplasms
• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	SN2310 Injectable Emulsion	Escalating doses given IV every three weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-12-01
• Completion: 2009-05-01
• First posted: 2006-10-06
• Last updated: 2009-06-04

Locations

2 sites across 1 country: United States