Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039780
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2002-06-10
Brief Title:
Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel
Sponsor:
BioNumerik Pharmaceuticals Inc
Organization:
BioNumerik Pharmaceuticals Inc
Study Overview
Official Title:
BNP7787 vs Placebo for Prevention of Paclitaxel Neurotoxicity A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None