Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel

July 11, 2022 updated by: BioNumerik Pharmaceuticals, Inc.

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

The purpose of this study is to determine whether BNP7787 is effective in preventing or reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

764

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

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 therapy

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

EXCLUSION CRITERIA

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 hypertension

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Tavocept (BNP7787)
Drug: BNP7787
The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
Other Names:
  • BNP7787 also known as Tavocept
Placebo Comparator: 2
0.9% Sodium Chloride Soln.
Drug: Placebo
The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: baseline to disease progression or discontinuation from study
baseline to disease progression or discontinuation from study

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Dose Modifications, Treatment Delays and Treatment Discontinuations due to Neurotoxicity
Time Frame: baseline to end of treatment
baseline to end of treatment
Time-to-onset of clinically important neurotoxicity
Time Frame: randomization to date of first occurrence of clinically important neurotoxicity
randomization to date of first occurrence of clinically important neurotoxicity
Incidence of Neurosensory and Neuromotor Functional Impairment
Time Frame: baseline through end of treatment
baseline through end of treatment
Progression Free Survival
Time Frame: Randomization to disease progression or death due to any cause
Randomization to disease progression or death due to any cause

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioNumerik Pharmaceuticals, Inc.

Collaborators

Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 10, 2002

First Submitted That Met QC Criteria

June 12, 2002

First Posted (Estimate)

June 13, 2002

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMS30203R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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