Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00039780
Other study ID # DMS30203R
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2001
Est. completion date September 2014

Study information

Verified date July 2022
Source BioNumerik Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 764
Est. completion date September 2014
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
BioNumerik Pharmaceuticals, Inc. Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Incidence of Dose Modifications, Treatment Delays and Treatment Discontinuations due to Neurotoxicity baseline to end of treatment
Secondary Time-to-onset of clinically important neurotoxicity randomization to date of first occurrence of clinically important neurotoxicity
Secondary Incidence of Neurosensory and Neuromotor Functional Impairment baseline through end of treatment
Secondary Progression Free Survival Randomization to disease progression or death due to any cause
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05558917 - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery N/A
Active, not recruiting NCT03664778 - Abbreviated Breast MRI After Cancer Treatment
Recruiting NCT03144622 - 18F-FSPG PET/CT Imaging in Patients With Cancers
Completed NCT05452499 - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae N/A
Active, not recruiting NCT04568902 - Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Phase 1
Completed NCT02860585 - Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation N/A
Completed NCT04059809 - Photobiomodulation for Breast Cancer Radiodermatitis Phase 2/Phase 3
Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Completed NCT03698942 - Delphinus SoftVue™ ROC Reader Study
Completed NCT00092950 - Exercise in Women at Risk for Breast Cancer Phase 2
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Not yet recruiting NCT02151071 - The Breast Surgery EnLight and LightPath Imaging System Study Phase 1/Phase 2
Recruiting NCT02934360 - TR(ACE) Assay Clinical Specimen Study N/A
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT02931552 - Nuevo Amanecer II: Translating a Stress Management Program for Latinas N/A
Not yet recruiting NCT02876848 - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study) N/A
Recruiting NCT02547545 - Breast Cancer Chemotherapy Risk Prediction Mathematical Model N/A
Completed NCT02518477 - Preventive Intervention Against Lymphedema After Breast Cancer Surgery N/A
Completed NCT02303366 - Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475 Phase 1
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A