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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454532
• Other study ID #: BZL-101-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 26, 2007
• Last updated: February 27, 2012
• Start date: March 2007

Study information

• Verified date: February 2012
• Source: Bionovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• BZL101
Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bionovo

References & 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 Can — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)	Best Overall Tumor Response - Investigator Assessment	2 Months	No
Primary	Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)	Best Overall Tumor Response - Independent Radiology Assessment	2 months	No