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

Completed · Phase 1

Conditions studied: Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Pelvic Neoplasms, Lung Neoplasms

In brief

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.

Key facts

Study ID

NCT00385177

Run by

Achieve Life Sciences

People needed

61

Starts

2006-09-01

Expected to finish

2009-05-01

Last updated by the study team

2009-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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