Clinical Trials /

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

NCT00907959

Description:

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-.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
  • Official Title: A Phase 2 Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: BZL-101-003
  • NCT ID: NCT00907959

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
BZL101

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-.

Trial Arms

NameTypeDescriptionInterventions

Eligibility 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:
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Bionovo

Last Updated

February 6, 2012