A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

Study Overview
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Brief Summary
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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 clinical data suggest that it is tolerable in patients with metastatic breast cancer. The overall goals of this Phase I/II trial are to assess the toxicity, maximum tolerated dose, safety and preliminary efficacy of BZL101 for the treatment of advanced metastatic breast cancer.

Official Title
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A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: BZL101


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BZL101|Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0 | Monthly | 
| Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Best Overall Tumor Response - Investigator Assessment | 2 Months | 
| Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Best Overall Tumor Response - Independent Radiology Assessment | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Bionovo, BZL101, Chinese Herbs