A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer (PEG-SN38)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01036113|
Recruitment Status : Unknown
Verified October 2012 by Enzon Pharmaceuticals, Inc..
Recruitment status was: Active, not recruiting
First Posted : December 21, 2009
Last Update Posted : October 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: EZN-2208||Phase 2|
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:
- AT Cohort - Patients treated with prior anthracycline and taxane as adjuvant or metastatic therapy; no more than 2 prior chemotherapy regimens for MBC
- ATX Cohort - Patients treated with prior anthracycline, taxane, and Xeloda® (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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients With Previously Treated Metastatic Breast Cancer (MBC)|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||June 2013|
Experimental: Experimental: EZN-2208
Experimental: EZN-2208 EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Other Name: Peg SN38
- Response Rate [ Time Frame: 2011 ]
- Progression Free Survival (PFS) [ Time Frame: 2011 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036113
Show 36 Study Locations
|Principal Investigator:||Joyce A O'Shaughnessy, MD||Texas Oncology-Baylor Charles A. Sarnrnons Cancer Center|