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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioNumerik Pharmaceuticals, Inc.
• Collaborator: Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.
• Treatments: 2,2'-dithiodiethanesulfonic acid; Albumin-Bound Paclitaxel; Mesna; Paclitaxel

Criteria

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:

• 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

EXCLUSION CRITERIA

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.