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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01036113
Other study ID # EZN-2208-03
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 2009
Est. completion date December 2012

Study information

Verified date October 2012
Source Enzon Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 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


Recruitment information / eligibility

Status Terminated
Enrollment 160
Est. completion date December 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed breast adenocarcinoma that is metastatic. Receptor status of the tumor must be known. - Disease progression during or after immediate previous therapy, or intolerable toxicity leading to cessation of immediate previous therapy - Previous treatment for MBC: - AT Cohort: Prior AT required as adjuvant or metastatic therapy; no more than 2 prior chemotherapy regimens for MBC. - ATX Cohort: Prior ATX required as adjuvant or metastatic therapy;no more than 4 prior chemotherapy regimens for MBC. - For patients with positive receptor status: - Patients with HER2+ MBC must have received prior trastuzumab. - Patients with ER+ MBC must have received prior hormone therapy. - Measurable disease by RECIST Version 1.1 - Women 18 years or older - ECOG performance status of 0 to 2 - Adequate bone marrow, renal and hepatic functions Exclusion Criteria: - Major surgery within 3 weeks before study start - Known or suspected brain metastases requiring intervention with steroids and/or radiation therapy - Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy used to treat the cancer within 3 weeks before scheduled administration of EZN-2208 - History of other primary cancer within 5 years of enrollment, unless 1. Curatively resected non-melanomatous skin cancer, or 2. Curatively resected cervical cancer - Lack of recovery to Grade 1 from any reversible side effects related to the administration of an investigational agent, chemotherapy, or other prior treatments for the cancer - Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an approved drug) in the 30 days before the first administration of EZN-2208 - Known chronic infectious disease, such as AIDS

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EZN-2208
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.

Locations

Country Name City State
United States Location #33 Abilene Texas
United States Location #34 Arlington Texas
United States Location #9 Austin Texas
United States Location #3 Bedford Texas
United States Location #15 Carmel Indiana
United States Location #16 Columbia Missouri
United States Location #41 Columbus Ohio
United States Location #13 Dallas Texas
United States Location #17 Dallas Texas
United States Location #26 Dallas Texas
United States Location #30 Dallas Texas
United States Location #18 Denver Colorado
United States Location #23 Fairfax Virginia
United States Location #24 Fort Worth Texas
United States Location #8 Greenville South Carolina
United States Location #2 Henderson Nevada
United States Location #11 Houston Texas
United States Location #14 Kansas City Missouri
United States Location #38 Lewisville Texas
United States Location #31 McAllen Texas
United States Location # 28 Midland Texas
United States Location #10 Minneapolis Minnesota
United States Location #32 Murrieta California
United States Location #36 New Port Richey Florida
United States Location #40 Niles Illinois
United States Location #7 Norfolk Virginia
United States Location #1 Ocoee Florida
United States Location #39 Oxnard California
United States Location #27 Portland Oregon
United States Location #4 Raleigh North Carolina
United States Location #21 Salem Virginia
United States Location #12 Sedona Arizona
United States Location #35 Sugar Land Texas
United States Location#19 Troy New York
United States Location #5 Tucson Arizona
United States Location# 20 Tyler Texas

Sponsors (1)

Lead Sponsor Collaborator
Enzon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response Rate 2011
Secondary Progression Free Survival (PFS) 2011
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