Status and phase
Conditions
Treatments
About
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.
Full 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:
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
Enrollment
Sex
Ages
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:
For patients with positive receptor status:
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
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 purpose
Allocation
Interventional model
Masking
160 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal