Phase 1 Dose Escalation Study Of SN2310 Injectable Emulsion In Patients With Advanced Solid Tumors

Study Overview

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

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.

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.

Breast Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Pelvic Neoplasms
Lung Neoplasms

DRUG: SN2310 Injectable Emulsion

SON-2310-06-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-10-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2009-06-02
First Submitted that Met QC Criteria 2006-10-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2009-06-04
First Posted (ESTIMATED) 2006-10-06	Results First Posted N/A	Last Verified 2009-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: A SN2310 Injectable Emulsion	DRUG: SN2310 Injectable Emulsion Escalating doses given IV every three weeks

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: A

SN2310 Injectable Emulsion

DRUG: SN2310 Injectable Emulsion

Escalating doses given IV every three weeks

Primary Outcome Measures	Measure Description	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Female who is pregnant or lactating
History of chronic diarrhea

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record