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

Phase 3

Completed

• Conditions: Breast Neoplasms; Metastases, Neoplasm; Breast Diseases
• Interventions: Drug: Placebo; Drug: BNP7787

• Registration Number: NCT00039780
• Lead Sponsor: BioNumerik Pharmaceuticals, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-06-10
• Study First Submitted QC: 2002-06-12
• Study First Posted: 2002-06-13
• Primary Completion: 2006-10
• Study Completion: 2014-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 764

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	0.9% Sodium Chloride Soln.
1	BNP7787	Tavocept (BNP7787)

Primary Outcome Measures

Name	Time	Method
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	baseline to disease progression or discontinuation from study

Secondary Outcome Measures

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