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

This study is not yet open for participant recruitment.
Verified February 2012 by Bionovo
Sponsor:
Information provided by:
Bionovo
ClinicalTrials.gov Identifier:
NCT00907959
First received: May 22, 2009
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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-.


Condition Intervention Phase
Metastatic Breast Cancer
 Drug: BZL101
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bionovo:

Primary Outcome Measures:
  • 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. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BZL101
    Oral BZL101 20 grams/day (10 grams BID).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907959

Contacts
Contact: Mary Tagliaferri, MD 5106012000 mary@bionovo.com

Locations
United States, Texas
M.D. Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Banu Arun, MD     713-792-2817     barun@mdanderson.org    
Principal Investigator: Banu Arun, MD            
Sponsors and Collaborators
Bionovo
  More Information

No publications provided

Responsible Party: Mary Tagliaferri, Chief Medical Officer, Bionovo
ClinicalTrials.gov Identifier: NCT00907959     History of Changes
Other Study ID Numbers: BZL-101-003
Study First Received: May 22, 2009
Last Updated: February 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013