NCT00454532

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 16, 2012

Completed
Last Updated

March 16, 2012

Status Verified

February 1, 2012

Enrollment Period

2.8 years

First QC Date

March 26, 2007

Results QC Date

February 27, 2012

Last Update Submit

February 27, 2012

Conditions

Metastatic Breast Cancer

Keywords

Breast CancerBionovoBZL101Chinese Herbs

Outcome Measures

Primary Outcomes (3)

  • Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)

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

    Monthly

  • Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)

    Best Overall Tumor Response - Investigator Assessment

    2 Months

  • Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)

    Best Overall Tumor Response - Independent Radiology Assessment

    2 months

Interventions

BZL101DRUG

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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. doi: 10.1007/s10549-009-0678-5.

    PMID: 20054647RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Scutellaria barbata extract

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Mary Tagliaferri, MD
Organization
Bionovo
clinicaltrials@bionovo.com
5106012000

Study Officials

  • Deborah Grady, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Charles Shapiro, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 30, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2009

Last Updated

March 16, 2012

Results First Posted

March 16, 2012

Record last verified: 2012-02