A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer

Status:	Archived
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	November 2009
End Date:	December 2011

A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients With Previously Treated Metastatic Breast Cancer (MBC)

This is a Phase 2, multicenter, open-label, noncomparative study to evaluate safety,efficacy
and of single-agent EZN 2208 administered in patients with previously treated MBC.

After discontinuation of study treatment, patients will receive care as considered
appropriate by the investigator. Patients will continue to be followed for disease
progression, subsequent anticancer therapy, and survival.

EZN-2208 will be administered by i.v. infusion weekly for 3 weeks in 4-week cycles. Study
treatment will be continued until evidence of disease progression, unacceptable toxicity, or
withdrawal of the patient's consent for participation in the study.

Approximately 160 patients with previously treated MBC will be enrolled in this study.
Eighty patients in each of two cohorts will be evaluated as follows:

1. AT Cohort - Patients treated with prior anthracycline and taxane as adjuvant or
metastatic therapy; no more than 2 prior chemotherapy regimens for MBC

2. ATX Cohort - Patients treated with prior anthracycline, taxane, and XelodaÂ®
(capecitabine) as adjuvant or metastatic therapy; no more than 4 prior chemotherapy
regimens for MBC

After discontinuation of study treatment, patients will receive care as considered
appropriate by the investigator. Patients will continue to be followed for disease
progression, subsequent anticancer therapy, and survival for at least 6 months after
enrollment of the last patient in the study

We found this trial at

sites

Clinical Trial Facility in Carmel Indiana

Carmel, Indiana 46032

from

Carmel, IN