A Phase 2 Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

Bionovo1 site in 1 country80 target enrollmentJanuary 2012

ConditionsMetastatic Breast Cancer

DrugsBZL101

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Metastatic Breast Cancer
Sponsor: Bionovo
Enrollment: 80
Locations: 1
Primary Endpoint: The primary outcomes of the Phase 2 trial will be safety and toxicity as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and tumor response rate defined by new RECIST criteria 1.1.
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators' proposed phase 2 clinical trial will be an open-label, non-randomized study among 80 women with metastatic breast cancer. The study treatment period will be up to twelve months and enrollment will be open at 10-15 clinical sites in the United States. In this Phase 2 trial, 40 participants with hormone receptor positive tumors and 40 with hormone receptor negative tumors will be enrolled and treated with BZL101 20 grams/day (10 grams BID). Hormone receptor positive will be defined as estrogen receptor (ER)+ and progesterone receptor (PR)+, ER+ and PR-, or ER- and PR+. Hormone receptor negative will be defined as ER- and PR-.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

July 2015

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bionovo

Eligibility Criteria

Inclusion Criteria

•Women 18 years or older.
•Histologically confirmed diagnosis of breast cancer based on pathology report of primary, regional or metastatic breast cancer.
•Clinical evidence of metastatic (stage IV) involvement other than bone only metastasis based on the investigator's clinical and/or radiographic findings.
•Availability of estrogen receptor and progesterone receptor status measured on biopsy tissue. (Status on the most recent biopsy where ER/PR status was documented will be used to determine hormone receptor status for stratification).
•At least one measurable disease site defined by RECIST criteria, with measurement made within 30 days of beginning study therapy. (Non-measurable disease includes bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions. For lesions in a previously irradiated field, the radiated lesion cannot be assessed as a measurable lesion unless growth of that lesion has been documented after radiation).
•No more than 2 prior cytotoxic regimens administered for metastatic breast cancer. (Participants may have received any number of exogenous hormone therapies for Stage IV disease and/or adjuvant therapy).
•Life expectancy of \>12 weeks.
•Eastern Cooperative Oncology Group performance status \<
•Women of child bearing potential must agree to use two adequate methods of contraception or abstain from sexual intercourse during study treatment. Acceptable methods of contraception are as follows:
•Intrauterine device (IUD)

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

The primary outcomes of the Phase 2 trial will be safety and toxicity as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and tumor response rate defined by new RECIST criteria 1.1.

Time Frame: Monthly