Clinical trial · Interventional
A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer
A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients With Previously Treated Metastatic Breast Cancer (MBC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Program suspended and divested
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EZN-2208 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: EZN-2208
- 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.
- interventionNames
- Drug: EZN-2208
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 2011
Secondary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 2011
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available