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BNP7787

Phase 3

Breast Neoplasms | Small molecule | Oncology |Lantern Pharma Inc.|Last Updated: Jul 13, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment764

FDA Designations

No designations recorded

Clinical trial landscape

BNP7787 · 1 trial · 3 indications

Phase 3 1
NCT00039780Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly PaclitaxelBreast Neoplasms
COMPLETED764 Analytics
PHASE3COMPLETED
Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel
Breast Neoplasms
NCT00039780764
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORTavocept (BNP7787)
2PLACEBO_COMPARATOR0.9% Sodium Chloride Soln.

Interventions

NameTypeDescription
BNP7787DRUGThe 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.
PlaceboDRUGThe 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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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

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 receivi...

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Frequently asked questions about BNP7787

What is BNP7787 used for?

BNP7787 is an investigational small molecule being studied for the prevention of neurotoxicity in metastatic breast cancer patients receiving weekly paclitaxel. It is in Phase 3 clinical development for breast neoplasms. The drug is being developed by Lantern Pharma Inc. (LTRN).

How does BNP7787 work?

BNP7787 is a small molecule being evaluated for its ability to prevent neurotoxicity in metastatic breast cancer patients receiving weekly paclitaxel. The specific molecular target of BNP7787 has not been disclosed. It is being studied as a preventive treatment for chemotherapy-induced neurotoxicity.

Who makes BNP7787?

BNP7787 is being developed by Lantern Pharma Inc., a biopharmaceutical company traded on the NASDAQ under the ticker LTRN. The company is conducting clinical research on BNP7787 as a potential preventive treatment for neurotoxicity in metastatic breast cancer patients.

What phase is BNP7787 in?

BNP7787 is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under clinical investigation for the prevention of neurotoxicity in metastatic breast cancer patients.

What clinical trials is BNP7787 in?

BNP7787 has been studied in a Phase 3 clinical trial with the identifier NCT00039780. This completed trial evaluated BNP7787 for the prevention of neurotoxicity in metastatic breast cancer patients receiving weekly paclitaxel. The trial enrolled 764 female participants aged 18 years and older.

Is BNP7787 the same as other drugs?

BNP7787 is the drug name used in clinical research. No alternative names have been reported for this investigational compound. It is being studied specifically for its potential to prevent neurotoxicity in metastatic breast cancer patients undergoing weekly paclitaxel treatment.