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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385177
• Other study ID #: SON-2310-06-101
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2006
• Last updated: June 2, 2009
• Start date: September 2006
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: OncoGenex Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• SN2310 Injectable Emulsion
Escalating doses given IV every three weeks

Locations

Country	Name	City	State
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
OncoGenex Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		December 2008	Yes
Primary	Dose-Limiting Toxicity		December 2008	Yes
Primary	Adverse Events		December 2008	Yes
Primary	Pharmacokinetic parameters for SN2310 and SN-38		December 2008	No