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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00454532
Recruitment Status : Completed
First Posted : March 30, 2007
Results First Posted : March 16, 2012
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):

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 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 or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: BZL101 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.
Study Start Date : March 2007
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) [ Time Frame: Monthly ]
    Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0

  2. Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) [ Time Frame: 2 Months ]
    Best Overall Tumor Response - Investigator Assessment

  3. Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) [ Time Frame: 2 months ]
    Best Overall Tumor Response - Independent Radiology Assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00454532

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

Publications of Results:
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Responsible Party: Bionovo Identifier: NCT00454532     History of Changes
Other Study ID Numbers: BZL-101-002
First Posted: March 30, 2007    Key Record Dates
Results First Posted: March 16, 2012
Last Update Posted: March 16, 2012
Last Verified: February 2012

Keywords provided by Bionovo:
Breast Cancer
Chinese Herbs

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