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BNP7787

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment764
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00039780Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly PaclitaxelPHASE3 COMPLETED 764 — — Sep 1, 2001Sep 1, 2014Jul 13, 2022 - —
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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 — 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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