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NM-3

Phase 1

Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: May 20, 2015

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00046696A Study of NM-3 Administered Orally in Patients With Advanced Solid Tumors.PHASE1 COMPLETED 32May 1, 2001Oct 1, 2006May 20, 20151 United States
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Study Endpoints
Primary Endpoints
MTD of NM-3 is the dose at which less than or equal to 1 of 6 patients experiences a DLT
Secondary Endpoints
Anti-tumor activity
VEGF and bFGF in urine, plasma and serum
Circulating endothelial cells
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
NM-3DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult patients at least 18 years of age. * All patients must have an advanced solid tumor that has failed standard therapy or for which no standard therapy exists. * Histological or cytological diagnosis of a malignant solid tumor. * Measurable or non-measurable disease. * Any...

Countries:United States
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