Recent Updates
Recently added Catalysts

Atrasentan

Phase 3

Prostatic Neoplasms | Small molecule | Oncology |Abbott Laboratories|Last Updated: Aug 15, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment1,141
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00036556Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate CancerPHASE3 COMPLETED 941 — — Jun 1, 2001 -Aug 15, 2007234 United States, Australia +15
NCT00038662Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical FailurePHASE2 COMPLETED 200 — — May 1, 2002 -Aug 15, 200640 United States, Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer.
Every 12 weeks
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AtrasentanDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range19 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites234

Inclusion Criteria: * Have been diagnosed with prostate cancer. * Have a rising PSA while on hormone therapy or following surgical castration. Exclusion Criteria: * Have evidence of distant metastatic disease on screening bone scan or CT scan. * Have received cytotoxic chemotherapy. * Have receiv...

Countries:United StatesAustraliaAustriaBelgiumCanadaFranceGermanyGreeceIrelandItalyNetherlandsNew ZealandPolandSouth AfricaSpainSwedenUnited Kingdom
Unlock Eligibility Criteria