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

NCT ID: NCT00454532

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

BZL101

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

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bionovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Grady, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Charles Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

References

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.

Reference Type: RESULT

PMID: 20054647 (View on PubMed)

Other Identifiers

BZL-101-002

Identifier Type: -

Identifier Source: org_study_id