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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bionovo
ClinicalTrials.gov Identifier:
NCT00454532
First received: March 26, 2007
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.

Resource links provided by NLM:

U.S. FDA Resources

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 ]
    Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0

  • Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) [ Time Frame: 2 Months ] [ Designated as safety issue: No ]
    Best Overall Tumor Response - Investigator Assessment

  • Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Best Overall Tumor Response - Independent Radiology Assessment


Enrollment: 27
Study Start Date: March 2007
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BZL101
    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

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

Publications:

Responsible Party: Bionovo
ClinicalTrials.gov Identifier: NCT00454532     History of Changes
Other Study ID Numbers: BZL-101-002
Study First Received: March 26, 2007
Results First Received: February 27, 2012
Last Updated: February 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bionovo:
Breast Cancer
Bionovo
BZL101
Chinese Herbs

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013