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Sponsored by: |
BioNumerik Pharmaceuticals, Inc. |
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Information provided by: | BioNumerik Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00039780 |
The purpose of this study is to determine whether BNP7787 is effective in preventing or reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®).
Condition | Intervention | Phase |
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Breast Neoplasms Breast Diseases Metastases, Neoplasm |
Drug: BNP7787 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer |
Enrollment: | 764 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | August 2009 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Tavocept (BNP7787)
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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.
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2: Placebo Comparator
0.9% Sodium Chloride Soln.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
EXCLUSION CRITERIA
Current CNS metastases or history of CNS metastases
History of diabetes (Type I or Type II)
Previous or concurrent malignancy except:
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.
Responsible Party: | BioNumerik ( BioNumerik (Chief Executive Officer) ) |
Study ID Numbers: | DMS30203R |
Study First Received: | June 10, 2002 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00039780 History of Changes |
Health Authority: | United States: Food and Drug Administration; Unitd States: WIRB; Russia: Ethics Committee; Russia: Pharmacological Committee, Ministry of Health |
Breast Cancer Metastatic Paclitaxel Peripheral Taxol Neuropathy |
Neurotoxicity Paresthesias Weekly BNP7787 7787 Tavocept Prevention |
Neurotoxicity Syndromes Skin Diseases Poisoning Breast Neoplasms Disorders of Environmental Origin Antimitotic Agents Paclitaxel |
Paresthesia Tubulin Modulators Neoplasm Metastasis Trastuzumab Antineoplastic Agents, Phytogenic Breast Diseases |
Molecular Mechanisms of Pharmacological Action Neurotoxicity Syndromes Skin Diseases Antineoplastic Agents Mitosis Modulators Nervous System Diseases Poisoning Breast Neoplasms Disorders of Environmental Origin Antimitotic Agents Pharmacologic Actions |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Paclitaxel Therapeutic Uses Tubulin Modulators Neoplasm Metastasis Antineoplastic Agents, Phytogenic Breast Diseases |