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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

2011

Safety Issue:

Yes

Principal Investigator

Joyce A O'Shaughnessy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas Oncology-Baylor Charles A. Sarnrnons Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EZN-2208-03

NCT ID:

NCT01036113

Start Date:

November 2009

Completion Date:

June 2013

Related Keywords:

  • Metastatic Breast Cancer
  • EZN-2208 (PEG-SN38)
  • Breast Neoplasms

Name

Location

Location #41Cincinnati, Ohio  45219
Location #12Sedona, Arizona  86336
Location #5Tucson, Arizona  85704
Location #32Murrieta, California  92562
Location #39Oxnard, California  93030
Location #18Denver, Colorado  80220
Location #36New Port Ritchey, Florida  34655
Location #1Ocoee, Florida  34761
Location #40Niles, Illinois  60714
Location #15Carmel, Indiana  46032
Location #10Minneapolis, Minnesota  55404
Location #16Columbia, Missouri  65201
Location #14Kansas City, Missouri  64131
Location #2Henderson, Nevada  89074
Location#19Troy, New York  12180
Location #4Raleigh, North Carolina  27607
Location #27Portland, Oregon  97213-2996
Location #8Greenville, South Carolina  29605
Location #33Abilene, Texas  79606
Location #34Arlington, Texas  76014
Location #9Austin, Texas  78705
Location #3Bedford, Texas  76022
Location #17Dallas, Texas  75246
Location #13Dallas, Texas  75231
Location #26Dallas, Texas  75230-2510
Location #30Dallas, Texas  75237
Location #24Fort Worth, Texas  76104
Location #11Houston, Texas  77024
Location #38Lewisville, Texas  75067
Location #31McAllen, Texas  78503
Location # 28Midland, Texas  79701
Location #35Sugarland, Texas  77479
Location# 20Tyler, Texas  75702
Location #23Fairfax, Virginia  22031
Location #7Norfolk, Virginia  23502
Location #21Salem, Virginia  24153