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

Phase 1

Completed

• Conditions: Breast Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Pelvic Neoplasms; Lung Neoplasms
• Interventions: Drug: SN2310 Injectable Emulsion

• Registration Number: NCT00385177
• Lead Sponsor: Achieve Life Sciences

Brief 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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Study First Posted: 2006-10-06
• Primary Completion: 2008-12
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-02
• Last Update Posted: 2009-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of solid tumor with disease progression despite standard therapy and/or for which no other solid therapeutic option exists
• ANC > 1,500 cell/mm3, platelets > 100,000/mm3 and Hgb > 9 g/dl
• At least one unidimensionally measurable lesion per RECIST
• Negative serum or urine pregnancy test, if female of childbearing potential

Exclusion Criteria

• Female who is pregnant or lactating
• History of chronic diarrhea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	SN2310 Injectable Emulsion	SN2310 Injectable Emulsion

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	December 2008
Dose-Limiting Toxicity	December 2008
Adverse Events	December 2008
Pharmacokinetic parameters for SN2310 and SN-38	December 2008

Trial Locations

Locations (2)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States