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

Metastatic Breast Cancer Clinical Trial

— PEG-SN38  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01036113
• Other study ID #: EZN-2208-03
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

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