NCT00385177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 4, 2009

Status Verified

June 1, 2009

Enrollment Period

2.3 years

First QC Date

October 3, 2006

Last Update Submit

June 2, 2009

Conditions

Breast NeoplasmsColorectal NeoplasmsPancreatic NeoplasmsPelvic NeoplasmsLung Neoplasms

Outcome Measures

Primary Outcomes (4)

  • Maximum Tolerated Dose

    December 2008

  • Dose-Limiting Toxicity

    December 2008

  • Adverse Events

    December 2008

  • Pharmacokinetic parameters for SN2310 and SN-38

    December 2008

Study Arms (1)

A

EXPERIMENTAL

SN2310 Injectable Emulsion

Drug: SN2310 Injectable Emulsion

Interventions

SN2310 Injectable EmulsionDRUG

Escalating doses given IV every three weeks

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsPancreatic NeoplasmsPelvic NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2006

First Posted

October 6, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2008

Study Completion

May 1, 2009

Last Updated

June 4, 2009

Record last verified: 2009-06

Locations

US(2)