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

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

Contacts


Contact: Mary Tagliaferri, MD	510-601-2000	clinicaltrials@bionovo.com

Locations


United States, California
	Breastlink Medical Group	Recruiting
	Long Beach, California, United States, 90806
	Contact: Kavita Belur 562-981-6101 ext 24 belur@breastlink.com
	Principal Investigator: Bichlien Nguyen, MD

United States, Florida
	Northwest Oncology & Hematology Associates	Recruiting
	Boca Raton, Florida, United States, 33428
	Contact: Alisha Stein, OCN 561-477-2759 astein@crinc.org
	Principal Investigator: Steven Weiss, MD
	Memorial Cancer Institute	Recruiting
	Hollywood, Florida, United States, 33021
	Contact: Gertrude Roth, RN, OCN 954-987-2020 groth@mhs.net
	Principal Investigator: Alejandra Perez, MD

United States, Illinois
	University of Chicago Medical Center	Recruiting
	Chicago, Illinois, United States, 60637
	Contact: Bernie Libao 773-834-1758 blibao@medicine.bsd.uchicago.edu
	Principal Investigator: Gini Fleming, MD

United States, New York
	Columbia University	Recruiting
	New York, New York, United States, 10032
	Contact: Alex Sierra 212-305-1964 as2903@columbia.edu
	Principal Investigator: Dawn Hershman, MD
	Montefiore Medical Center	Recruiting
	Bronx, New York, United States, 10461
	Contact: Patricia Rodrigues-McGrath 718-405-8539 PARODRIG@montefiore.org
	Principal Investigator: Tianhong Li, MD

United States, North Carolina
	Duke University Medical Center	Recruiting
	Durham, North Carolina, United States, 27710
	Contact: Vlayka Liocheva 919-684-5720 vlayka.liocheva@duke.edu
	Principal Investigator: Heather Shaw, MD

United States, Ohio
	Ohio State University Comprehensive Cancer Center	Recruiting
	Columbus, Ohio, United States, 43210
	Contact: Linda Houton 614-293-0541 linda.houton@osumc.edu
	Principal Investigator: Ewa Mrozek, MD

United States, Texas
	University of Texas Southwestern Medical Center	Recruiting
	Dallas, Texas, United States, 75390
	Contact: Mishel Davis 214-648-7021 Mishel.Davis@UTSouthwestern.edu
	Principal Investigator: Jenny Li, MD

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

Responsible Party:	Bionovo, Inc ( Chief Medical Officer )
Study ID Numbers:	BZL-101-002
First Received:	March 26, 2007
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00454532
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

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 21, 2008

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