Clinical trial NCT01036113: A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer
Official title: A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients With Previously Treated Metastatic Breast Cancer (MBC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: EZN-2208 (PEG-SN38)
Lead sponsor: Enzon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Response Rate
timeFrame: 2011
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 2011
Other outcomes:
Locations:
city: Sedona
country: United States
facility: Location #12
state: Arizona
city: Tucson
country: United States
facility: Location #5
state: Arizona
city: Murrieta
country: United States
facility: Location #32
state: California
city: Oxnard
country: United States
facility: Location #39
state: California
city: Denver
country: United States
facility: Location #18
state: Colorado
city: New Port Richey
country: United States
facility: Location #36
state: Florida
city: Ocoee
country: United States
facility: Location #1
state: Florida
city: Niles
country: United States
facility: Location #40
state: Illinois
city: Carmel
country: United States
facility: Location #15
state: Indiana
city: Minneapolis
country: United States
facility: Location #10
state: Minnesota
city: Columbia
country: United States
facility: Location #16
state: Missouri
city: Kansas City
country: United States
facility: Location #14
state: Missouri
city: Henderson
country: United States
facility: Location #2
state: Nevada
city: Troy
country: United States
facility: Location#19
state: New York
city: Raleigh
country: United States
facility: Location #4
state: North Carolina
city: Columbus
country: United States
facility: Location #41
state: Ohio
city: Portland
country: United States
facility: Location #27
state: Oregon
city: Greenville
country: United States
facility: Location #8
state: South Carolina
city: Abilene
country: United States
facility: Location #33
state: Texas
city: Arlington
country: United States
facility: Location #34
state: Texas
city: Austin
country: United States
facility: Location #9
state: Texas
city: Bedford
country: United States
facility: Location #3
state: Texas
city: Dallas
country: United States
facility: Location #26
state: Texas
city: Dallas
country: United States
facility: Location #13
state: Texas
city: Dallas
country: United States
facility: Location #30
state: Texas
city: Dallas
country: United States
facility: Location #17
state: Texas
city: Fort Worth
country: United States
facility: Location #24
state: Texas
city: Houston
country: United States
facility: Location #11
state: Texas
city: Lewisville
country: United States
facility: Location #38
state: Texas
city: McAllen
country: United States
facility: Location #31
state: Texas
city: Midland
country: United States
facility: Location # 28
state: Texas
city: Sugar Land
country: United States
facility: Location #35
state: Texas
city: Tyler
country: United States
facility: Location# 20
state: Texas
city: Fairfax
country: United States
facility: Location #23
state: Virginia
city: Norfolk
country: United States
facility: Location #7
state: Virginia
city: Salem
country: United States
facility: Location #21
state: Virginia
Study officials:
affiliation: Texas Oncology-Baylor Charles A. Sarnrnons Cancer Center
name: Joyce A O'Shaughnessy, MD
role: PRINCIPAL_INVESTIGATOR
References: