Status:
COMPLETED
A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
Lead Sponsor:
Bionovo
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. Preclinical studies suggest that this herb has antitumor activity for breast cancer and preliminary clinica...
Eligibility Criteria
Inclusion
- Key
- Women 18 years or older
- Histologically confirmed breast cancer
- Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)
- Availability of estrogen and progesterone receptor status
- At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy
- For the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. For the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group performance status ≤2
- Women of child bearing potential must agree to 2 forms of contraception during the course of the trial.
- Key
Exclusion
- Inability to understand/unwillingness to sign a written informed consent
- Any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator
- Currently using an investigational agent
- Clinically significant gastrointestinal abnormalities
- Currently using coumadin at therapeutic doses or within 2 weeks of taking study medication
- Concurrent palliative radiation or anti-cancer treatment
- Women who report pregnancy, are breast-feeding or have a positive pregnancy test
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00454532
Start Date
March 1 2007
Last Update
March 16 2012
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