NCT00286247

Brief Summary

A maximum of 60 subjects will be enrolled in the trial. It is a non-randomized, open label, single center study. All subjects undergo INGN 201 injection and IV chemotherapy: doxorubicin and docetaxel. This is done on the first 2 days of a 3-week cycle. After completion of 4 to 6 cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off study if there is no tumor response.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

First QC Date

February 1, 2006

Last Update Submit

March 28, 2008

Conditions

Locally Advanced Breast Cancer (LABC)

Interventions

INGN 201GENETIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Documented late stage breast cancer: stage III A-B (excluding inflammatory breast carcinoma) or localized stage IV breast cancer Male or female 18 years or older Adequate bone marrow, liver, and kidney function

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

advexin

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

US(1)