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

This study is ongoing, but not recruiting participants.

First Received: March 26, 2007 Last Updated: April 2, 2009 History of Changes

Sponsored by:	Bionovo
Information provided by:	Bionovo
ClinicalTrials.gov Identifier:	NCT00454532

Purpose

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.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: BZL101	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.

Further study details as provided by Bionovo:

Primary Outcome Measures:

Toxicity based upon adverse events classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) [ Time Frame: 2 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454532

Locations

United States, California
Breastlink Medical Group
Long Beach, California, United States, 90806
UCSF - Breast Cancer Center
San Francisco, California, United States, 94115
University of Southern California
Los Angeles, California, United States, 90033
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
United States, Florida
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Lynn Regional Cancer Center
Boca Raton, Florida, United States, 33486
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, New York
Columbia University
New York, New York, United States, 10032
Montefiore Medical Center
Bronx, New York, United States, 10461
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390

Sponsors and Collaborators

Bionovo

Investigators

Principal Investigator:	Deborah Grady, M.D.	University of California, San Francisco
Principal Investigator:	Charles Shapiro, MD	Ohio State University

More Information

No publications provided

Responsible Party:	Bionovo, Inc ( Chief Medical Officer )
Study ID Numbers:	BZL-101-002
Study First Received:	March 26, 2007
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00454532 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bionovo:

Breast Cancer
Bionovo
BZL101
Chinese Herbs

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Marijuana Abuse
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009