Study Stopped
Program suspended and divested
A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer
PEG-SN38
A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients With Previously Treated Metastatic Breast Cancer (MBC)
1 other identifier
interventional
160
1 country
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2009
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 17, 2009
CompletedFirst Posted
Study publicly available on registry
December 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 14, 2022
October 1, 2012
2.3 years
December 17, 2009
January 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate
2011
Secondary Outcomes (1)
Progression Free Survival (PFS)
2011
Study Arms (1)
Experimental: EZN-2208
EXPERIMENTALExperimental: EZN-2208 EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Interventions
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Curatively resected non-melanomatous skin cancer, or
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Location #12
Sedona, Arizona, 86336, United States
Location #5
Tucson, Arizona, 85704, United States
Location #32
Murrieta, California, 92562, United States
Location #39
Oxnard, California, 93030, United States
Location #18
Denver, Colorado, 80220, United States
Location #36
New Port Richey, Florida, 34655, United States
Location #1
Ocoee, Florida, 34761, United States
Location #40
Niles, Illinois, 60714, United States
Location #15
Carmel, Indiana, 46032, United States
Location #10
Minneapolis, Minnesota, 55404, United States
Location #16
Columbia, Missouri, 65201, United States
Location #14
Kansas City, Missouri, 64131, United States
Location #2
Henderson, Nevada, 89074, United States
Location#19
Troy, New York, 12180, United States
Location #4
Raleigh, North Carolina, 27607, United States
Location #41
Columbus, Ohio, 43219, United States
Location #27
Portland, Oregon, 97213-2996, United States
Location #8
Greenville, South Carolina, 29605, United States
Location #33
Abilene, Texas, 79606, United States
Location #34
Arlington, Texas, 76014, United States
Location #9
Austin, Texas, 78705, United States
Location #3
Bedford, Texas, 76022, United States
Location #26
Dallas, Texas, 75230-2510, United States
Location #13
Dallas, Texas, 75231, United States
Location #30
Dallas, Texas, 75237, United States
Location #17
Dallas, Texas, 75246, United States
Location #24
Fort Worth, Texas, 76104, United States
Location #11
Houston, Texas, 77024, United States
Location #38
Lewisville, Texas, 75067, United States
Location #31
McAllen, Texas, 78503, United States
Location # 28
Midland, Texas, 79701, United States
Location #35
Sugar Land, Texas, 77479, United States
Location# 20
Tyler, Texas, 75702, United States
Location #23
Fairfax, Virginia, 22031, United States
Location #7
Norfolk, Virginia, 23502, United States
Location #21
Salem, Virginia, 24153, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joyce A O'Shaughnessy, MD
Texas Oncology-Baylor Charles A. Sarnrnons Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2009
First Posted
December 21, 2009
Study Start
November 1, 2009
Primary Completion
February 1, 2012
Study Completion
December 1, 2012
Last Updated
February 14, 2022
Record last verified: 2012-10