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

NCT00039780 | Completed Phase 3 DMC

• 1 other identifier: DMS30203R
• Study Type: interventional
• Target: 764
• Locations: 0 countries
• Sites: N/A

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®).

Conditions

Breast Neoplasms; Breast Diseases; Metastases, Neoplasm

Keywords

Breast; Cancer; Metastatic; Paclitaxel; Peripheral; Taxol; Neuropathy; Neurotoxicity; Paresthesias; Weekly; BNP7787; 7787; Tavocept; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Incidence of Neurosensory and Neuromotor Functional Impairment

  baseline through end of treatment

• Progression Free Survival

  Randomization to disease progression or death due to any cause

Study Arms (2)

1

ACTIVE COMPARATOR

Tavocept (BNP7787)

Drug: BNP7787

2

PLACEBO COMPARATOR

0.9% Sodium Chloride Soln.

Drug: Placebo

Interventions

BNP7787 DRUG

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.

Also known as: BNP7787 also known as Tavocept

1

Placebo DRUG

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented metastatic breast cancer
• Measurable disease
• Performance Status; ECOG 0-2
• More than 2 weeks since prior radiation therapy
• 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:
• Granulocytes greater than or equal to 1,500/mm(3)
• Platelets greater than or equal to 100,000/mm(3)
• Hemoglobin greater than or equal to 9 g/dL
• SGOT less than 2.0 x ULN
• Bilirubin less than or equal to 1.5 mg/dL
• Creatinine less than or equal to 1.6 mg/dL
• Calcium less than the ULN

You may not qualify if:

• Current CNS metastases or history of CNS metastases
• History of diabetes (Type I or Type II)
• Previous or concurrent malignancy except:
• inactive non-melanoma skin cancer
• in situ carcinoma of the cervix
• or other cancer if the patient has been disease-free for more than 5 years
• 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.

Sponsors & Collaborators

• BioNumerik Pharmaceuticals, Inc.: lead
• Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases; Neoplasm Metastasis; Neoplasms; Neurotoxicity Syndromes; Paresthesia

Interventions

2,2'-dithiodiethanesulfonic acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2002
• First Posted: June 13, 2002
• Study Start: September 1, 2001
• Primary Completion: October 1, 2006
• Study Completion: September 1, 2014
• Last Updated: July 13, 2022

Record last verified: 2022-07