Clinical trial NCT00454532: A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
Official title: A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer
Bionovo
BZL101
Chinese Herbs
Lead sponsor: Bionovo
Sponsor class: INDUSTRY
First posted: 2007-03-30
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)
timeFrame: Monthly
measure: Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
timeFrame: 2 Months
measure: Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Deborah Grady, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Charles Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.