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

NCT00039780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 764

Last updated 2022-07-13

No results posted yet for this study

Summary

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

Conditions

  • Breast Neoplasms
  • Breast Diseases
  • Metastases, Neoplasm

Interventions

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.

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.

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • BioNumerik Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2006-10-31
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00039780 on ClinicalTrials.gov