A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer (PEG-SN38)
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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) |
- Response Rate [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]
- 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:
- 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 36 Study Locations| 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 Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013