Clinical Trial: Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer
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 Summary:
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.
Sponsor: BioNumerik Pharmaceuticals, Inc.
Current Primary Outcome: 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 ]
Original Primary Outcome:
Current Secondary Outcome:
- Incidence of Dose Modifications, Treatment Delays and Treatment Discontinuations due to Neurotoxicity [ Time Frame: baseline to end of treatment ]
- Time-to-onset of clinically important neurotoxicity [ Time Frame: randomization to date of first occurrence of clinically important neurotoxicity ]
- Incidence of Neurosensory and Neuromotor Functional Impairment [ Time Frame: baseline through end of treatment ]
- Progression Free Survival [ Time Frame: Randomization to disease progression or death due to any cause ]
Original Secondary Outcome:
Information By: BioNumerik Pharmaceuticals, Inc.
Dates:
Date Received: June 10, 2002
Date Started: September 2001
Date Completion:
Last Updated: January 9, 2017
Last Verified: January 2017
