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A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer (PEG-SN38)

Primary Purpose

Metastatic Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EZN-2208
Sponsored by
Enzon Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring EZN-2208 (PEG-SN38)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Location #12
  • Location #5
  • Location #32
  • Location #39
  • Location #18
  • Location #36
  • Location #1
  • Location #40
  • Location #15
  • Location #10
  • Location #16
  • Location #14
  • Location #2
  • Location#19
  • Location #4
  • Location #41
  • Location #27
  • Location #8
  • Location #33
  • Location #34
  • Location #9
  • Location #3
  • Location #26
  • Location #13
  • Location #30
  • Location #17
  • Location #24
  • Location #11
  • Location #38
  • Location #31
  • Location # 28
  • Location #35
  • Location# 20
  • Location #23
  • Location #7
  • Location #21

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: EZN-2208

Arm Description

Experimental: EZN-2208 EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Progression Free Survival (PFS)

Full Information

First Posted
December 17, 2009
Last Updated
January 29, 2022
Sponsor
Enzon Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01036113
Brief Title
A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer
Acronym
PEG-SN38
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Program suspended and divested
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enzon Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: AT Cohort - Patients treated with prior anthracycline and taxane as adjuvant or metastatic therapy; no more than 2 prior chemotherapy regimens for MBC 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
EZN-2208 (PEG-SN38)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: EZN-2208
Arm Type
Experimental
Arm Description
Experimental: EZN-2208 EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Intervention Type
Drug
Intervention Name(s)
EZN-2208
Other Intervention Name(s)
Peg SN38
Intervention Description
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
2011
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
2011

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce A O'Shaughnessy, MD
Organizational Affiliation
Texas Oncology-Baylor Charles A. Sarnrnons Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Location #12
City
Sedona
State/Province
Arizona
ZIP/Postal Code
86336
Country
United States
Facility Name
Location #5
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Location #32
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Location #39
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Location #18
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Location #36
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Location #1
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Location #40
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Location #15
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Location #10
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Location #16
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Location #14
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Location #2
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Location#19
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
Location #4
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Location #41
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Location #27
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2996
Country
United States
Facility Name
Location #8
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Location #33
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Location #34
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Location #9
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Location #3
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Location #26
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-2510
Country
United States
Facility Name
Location #13
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Location #30
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Location #17
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Location #24
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Location #11
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Location #38
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
Facility Name
Location #31
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Location # 28
City
Midland
State/Province
Texas
ZIP/Postal Code
79701
Country
United States
Facility Name
Location #35
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Location# 20
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Location #23
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Location #7
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Location #21
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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