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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00385177

Enrollment

Registered

2006-10-06

Start date

2006-09-30

Completion date

2009-05-31

Last updated

2009-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Pelvic Neoplasms

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.

Interventions

DRUGSN2310 Injectable Emulsion

Escalating doses given IV every three weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026