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Menadione

Phase 1

EGFR Inhibitor-associated Rash | Small molecule | Other |Assertio Holdings, Inc.|Last Updated: Nov 13, 2020

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-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00656786Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated RashPHASE1 COMPLETED 18Apr 3, 2008Dec 30, 2009Nov 13, 20207 United States, Canada
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Study Endpoints
Primary Endpoints
To evaluate safety, tolerability and systemic absorption of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
6 weeks
Secondary Endpoints
To evaluate skin rash status as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALSubjects will be treated if, after starting treatment with an EGFRi, acute signs and symptoms of rash on the face/neck and/or upper chest emerge, that are suspected of being related to the EGFRi treatment.
Group 2EXPERIMENTALSubjects will receive pre-emergent rash treatment starting 1 day prior to beginning EGFRi therapy
Interventions
NameTypeDescription
Menadione Topical LotionDRUGMenadione Lotion will be applied topically twice a day; beginning when the rash appears during EGFRi therapy.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Male or female subjects at least 18 years old; 2. Have been prescribed an approved EGFRI to treat cancer and expect to begin this treatment within 14 days (i.e., any EGFRI that is approved for the treatment of cancer at the time of subject enrollment); 3. For Group 1: Agree t...

Countries:United StatesCanada
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