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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achieve Life Sciences; OncoGenex Technologies

Criteria

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