Clinical trial · Interventional
Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel
BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer
NCT00039780CI-TRIAL-00059626completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether BNP7787 is effective in preventing or reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Diseases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastases, Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BNP7787 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Tavocept (BNP7787)
- interventionNames
- Drug: BNP7787
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- 0.9% Sodium Chloride Soln.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- 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
- timeFrame
- baseline to disease progression or discontinuation from study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.