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

Phase 1

Completed

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT00454532
• Lead Sponsor: Bionovo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-26
• Study First Submitted QC: 2007-03-29
• Study First Posted: 2007-03-30
• Primary Completion: 2009-12
• Status Verified: 2012-02
• Results First Submitted: 2012-02-27
• Results First Submitted QC: 2012-02-27
• Last Update Submitted: 2012-02-27
• Results First Posted: 2012-03-16
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)	Monthly	Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)	2 months	Best Overall Tumor Response - Independent Radiology Assessment