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CEP-37440

Phase 1

Solid Tumors | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Nov 12, 2021

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
NCT01922752To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid TumorsPHASE1 COMPLETED 32Jul 1, 2013Dec 1, 2015Nov 12, 20213 United States
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Study Endpoints
Primary Endpoints
Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
8 months
Secondary Endpoints
Time to Response (TTR)
8 months
Number of participants with adverse events
From signing of the informed consent to the end of the follow-up visit (approximately Month 10)
Time to Progression (TTP)
8 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CEP-37440EXPERIMENTAL -
Interventions
NameTypeDescription
CEP-37440DRUGCEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily. Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy. * Patients must have evidence of recurrent, locally advanced, or metastatic d...

Countries:United States
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