A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

A Phase 2 Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

The investigators' proposed phase 2 clinical trial will be an open-label, non-randomized study among 80 women with metastatic breast cancer. The study treatment period will be up to twelve months and enrollment will be open at 10-15 clinical sites in the United States. In this Phase 2 trial, 40 participants with hormone receptor positive tumors and 40 with hormone receptor negative tumors will be enrolled and treated with BZL101 20 grams/day (10 grams BID). Hormone receptor positive will be defined as estrogen receptor (ER)+ and progesterone receptor (PR)+, ER+ and PR-, or ER- and PR+. Hormone receptor negative will be defined as ER- and PR-.

Study Overview

• Status: Unknown
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: BZL101

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mary Tagliaferri, MD; Phone Number: 5106012000; Email: mary@bionovo.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M.D. Anderson Cancer Center
      • Contact: Banu Arun, MD; Phone Number: 713-792-2817; Email: barun@mdanderson.org
      • Principal Investigator: Banu Arun, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women 18 years or older.
2. Histologically confirmed diagnosis of breast cancer based on pathology report of primary, regional or metastatic breast cancer.
3. Clinical evidence of metastatic (stage IV) involvement other than bone only metastasis based on the investigator's clinical and/or radiographic findings.
4. Availability of estrogen receptor and progesterone receptor status measured on biopsy tissue. (Status on the most recent biopsy where ER/PR status was documented will be used to determine hormone receptor status for stratification).
5. At least one measurable disease site defined by RECIST criteria, with measurement made within 30 days of beginning study therapy. (Non-measurable disease includes bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions. For lesions in a previously irradiated field, the radiated lesion cannot be assessed as a measurable lesion unless growth of that lesion has been documented after radiation).
6. No more than 2 prior cytotoxic regimens administered for metastatic breast cancer. (Participants may have received any number of exogenous hormone therapies for Stage IV disease and/or adjuvant therapy).
7. Life expectancy of >12 weeks.
8. Eastern Cooperative Oncology Group performance status <2.

9. Women of child bearing potential must agree to use two adequate methods of contraception or abstain from sexual intercourse during study treatment. Acceptable methods of contraception are as follows:

   1. Intrauterine device (IUD)
   2. Hormonal birth control
   3. Tubal ligation
   4. Partner's vasectomy
   5. Latex condom
   6. Diaphragm
   7. Cervical cap
10. Adequate organ and marrow function measured within 14 days of study treatment as defined below:

Absolute neutrophil count >1,500 cells/mm3 Platelets >100,000 cells/mm3 Hemoglobin >10 g/dL Total bilirubin <1.5 mg/dL AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal or <5 X normal with documented liver metastasis Alkaline Phosphatase <3 X institutional upper limit of normal or <5 X normal with documented liver or bone metastasis Serum creatinine <1.5 mg/dL or Creatinine clearance >60 mL/min/1.73 m2 for participants with serum creatinine levels above institutional normal.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcomes of the Phase 2 trial will be safety and toxicity as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and tumor response rate defined by new RECIST criteria 1.1.	Monthly

Collaborators and Investigators

• Sponsor: Bionovo

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: May 22, 2009
• First Submitted That Met QC Criteria: May 22, 2009
• First Posted (Estimate): May 25, 2009

Study Record Updates

• Last Update Posted (Estimate): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 6, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BZL-101-003