A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer
NCT ID: NCT01036113
Last Updated: 2022-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
160 participants
INTERVENTIONAL
2009-11-30
2012-12-31
Brief Summary
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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.
Detailed Description
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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
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Interventions
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EZN-2208
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Enzon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joyce A O'Shaughnessy, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Oncology-Baylor Charles A. Sarnrnons Cancer Center
Locations
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Location #12
Sedona, Arizona, United States
Location #5
Tucson, Arizona, United States
Location #32
Murrieta, California, United States
Location #39
Oxnard, California, United States
Location #18
Denver, Colorado, United States
Location #36
New Port Richey, Florida, United States
Location #1
Ocoee, Florida, United States
Location #40
Niles, Illinois, United States
Location #15
Carmel, Indiana, United States
Location #10
Minneapolis, Minnesota, United States
Location #16
Columbia, Missouri, United States
Location #14
Kansas City, Missouri, United States
Location #2
Henderson, Nevada, United States
Location#19
Troy, New York, United States
Location #4
Raleigh, North Carolina, United States
Location #41
Columbus, Ohio, United States
Location #27
Portland, Oregon, United States
Location #8
Greenville, South Carolina, 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 #26
Dallas, Texas, United States
Location #13
Dallas, Texas, United States
Location #30
Dallas, Texas, United States
Location #17
Dallas, Texas, United States
Location #24
Fort Worth, Texas, United States
Location #11
Houston, Texas, United States
Location #38
Lewisville, Texas, United States
Location #31
McAllen, Texas, United States
Location # 28
Midland, Texas, United States
Location #35
Sugar Land, Texas, United States
Location# 20
Tyler, Texas, United States
Location #23
Fairfax, Virginia, United States
Location #7
Norfolk, Virginia, United States
Location #21
Salem, Virginia, United States
Countries
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Other Identifiers
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EZN-2208-03
Identifier Type: -
Identifier Source: org_study_id