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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01036113
First received: December 17, 2009
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: EZN-2208
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients With Previously Treated Metastatic Breast Cancer (MBC)

Resource links provided by NLM:


Further study details as provided by Enzon Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: November 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: EZN-2208
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Other Name: Peg SN38

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036113

  Show 36 Study Locations
Sponsors and Collaborators
Enzon Pharmaceuticals, Inc.
Investigators
Principal Investigator: Joyce A O'Shaughnessy, MD Texas Oncology-Baylor Charles A. Sarnrnons Cancer Center
  More Information

No publications provided

Responsible Party: Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01036113     History of Changes
Other Study ID Numbers: EZN-2208-03
Study First Received: December 17, 2009
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Enzon Pharmaceuticals, Inc.:
EZN-2208 (PEG-SN38)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014