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

March 26, 2007
February 27, 2012
March 2007
December 2009   (final data collection date for primary outcome measure)
  • 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
  • NCI Common Terminology Criteria for Adverse Events
  • Response Evaluation Criteria In Solid Tumors (RECIST)
Complete list of historical versions of study NCT00454532 on ClinicalTrials.gov Archive Site
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A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: BZL101
Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.
Not Provided
Perez AT, Arun B, Tripathy D, Tagliaferri MA, Shaw HS, Kimmick GG, Cohen I, Shtivelman E, Caygill KA, Grady D, Schactman M, Shapiro CL. A phase 1B dose escalation trial of Scutellaria barbata (BZL101) for patients with metastatic breast cancer. Breast Cancer Res Treat. 2010 Feb;120(1):111-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00454532
BZL-101-002
Yes
Bionovo
Bionovo
Not Provided
Principal Investigator: Deborah Grady, M.D. University of California, San Francisco
Principal Investigator: Charles Shapiro, MD Ohio State University
Bionovo
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP