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BAY1075553

Phase 1

Diagnostic Imaging | Small molecule | Other |Lantheus Holdings, Inc.|Last Updated: Jan 21, 2013

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01287845PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy VolunteersPHASE1 COMPLETED 14Feb 1, 2011Nov 1, 2011Jan 21, 20132 United States, Austria
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Study Endpoints
Primary Endpoints
Safety parameters, for example laboratory and electrocardiogram abnormalities
Day 2
Effective radiation dose given in mSv (milliSievert) in healthy volunteers
Day 1
Secondary Endpoints
Overall lesion detection rate
Day 1
Lesion detection rate in comparison to histology, where available (cancer lesion detection rate)
Day 1
Lesion detection rate in comparison to MRI (Magnetic Resonance Imaging) and/or [11C] (11Carbon)- or [18F] (18Fluor)-choline PET/CT (whenever available)
Day 1
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Interventions
NameTypeDescription
BAY1075553DRUGCancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Part 1: Healthy volunteers only \-- Males ≥ 40 years of age * Part 2: Prostate cancer patients * Males ≥ 18 years of age * Serum PSA (Prostate-Specific Antigen) value above normal. * Patients had an MRI and/or a positive \[11C\] - or \[18F\] -choline PET/CT for prima...

Countries:United StatesAustria
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Competitive Landscape -Diagnostic and Imaging 9 trials