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

B

Bionovo

Status and phase

Completed
Phase 2
Phase 1

Conditions

Metastatic Breast Cancer

Treatments

Drug: BZL101

Study type

Interventional

Funder types

Industry

Identifiers

NCT00454532
BZL-101-002

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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