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BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Neoplasms, Breast Diseases, Metastases, Neoplasm

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Trial Information

BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer

Chemotherapy induced toxicities are common and serious problems for many patients who
receive treatment for cancer. Chemotherapy induced toxicities can adversely impact the
quality of life and the ability of patients to continue treatment for their cancer. One
such toxicity associated with the use of paclitaxel (Taxol®) is peripheral neurotoxicity.

Paclitaxel is an active drug in the treatment of metastatic breast cancer as first-line
treatment and in patients with recurrent or refractory disease, including patients who have
failed to respond to previous anthracycline therapy. Recent studies with paclitaxel using a
weekly schedule of administration have demonstrated higher tumor response rates and disease
free survival accompanied by a shift in the frequency of certain toxicities, increased dose
intensity and a potential means to improve the treatment schedule of paclitaxel for improved
patient benefit.

Paclitaxel induced neurotoxicity remains an important problem that limits the ability to
improve the schedule of administration of this drug. To date, there is no effective or FDA
approved therapy to prevent the development of or reduce the frequency or severity of
paclitaxel-induced neurotoxicity.

BNP7787 is an investigational new drug that is undergoing development for chemoprotection of
platinum and taxane associated common clinical toxicities, particularly the prevention of
chemotherapy-induced neurotoxicity.

In this Phase 3 clinical trial the safety and effectiveness of BNP7787 in preventing or
mitigating the frequency, severity, worsening of grade, time to onset, duration and
discontinuation of therapy due to paclitaxel-induced neurotoxicity will be assessed in
patients with metastatic breast cancer.

Inclusion Criteria


Histologically or cytologically documented metastatic breast cancer

Measurable disease

Performance Status; ECOG 0-2

More than 2 weeks since prior radiation therapy

14 days or more since prior therapy and recovered from all side effects

For patients who progress while receiving hormonal therapy alone, the patient may be
enrolled on study as soon as they have recovered from all side effects of the hormonal

Clinical laboratory values must meet the following:

- Granulocytes greater than or equal to 1,500/mm(3)

- Platelets greater than or equal to 100,000/mm(3)

- Hemoglobin greater than or equal to 9 g/dL

- SGOT less than 2.0 x ULN

- Bilirubin less than or equal to 1.5 mg/dL

- Creatinine less than or equal to 1.6 mg/dL

- Calcium less than the ULN


Current CNS metastases or history of CNS metastases

History of diabetes (Type I or Type II)

Previous or concurrent malignancy except:

- inactive non-melanoma skin cancer

- in situ carcinoma of the cervix

- or other cancer if the patient has been disease-free for more than 5 years

Pregnant or lactating women

History of recent myocardial infarction, stroke, or uncontrolled CHF, epilepsy, or

Patients currently receiving Neurontin® (gabapentin), glutamine supplements, Elavil®
(amitriptyline), Dilantin®, Tegretol®, tricyclic antidepressants or other similar
medications during the study period

Alternative medications including megadose vitamins, herbal preparations, tonics,
extracts, etc. are not allowed during the study period.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

1)Incidence of PNQ Grade D or Grade E neurosensory symptoms (Item 1 of the PNQ) with duration of at least 4 weks; 2) Objective tumor response rate

Outcome Time Frame:

baseline to disease progression or discontinuation from study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

September 2014

Related Keywords:

  • Breast Neoplasms
  • Breast Diseases
  • Metastases, Neoplasm
  • Breast
  • Cancer
  • Metastatic
  • Paclitaxel
  • Peripheral
  • Taxol
  • Neuropathy
  • Neurotoxicity
  • Paresthesias
  • Weekly
  • BNP7787
  • 7787
  • Tavocept
  • Prevention
  • Breast Neoplasms
  • Breast Diseases
  • Neoplasms
  • Neoplasm Metastasis
  • Neurotoxicity Syndromes