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Bombesin labeled

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01205321PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy VolunteersPHASE1 COMPLETED 19Nov 1, 2010Dec 1, 2011Jan 21, 20133 Finland, Germany +1
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Study Endpoints
Primary Endpoints
Visual assessment of lesions
Day of study drug administration
Secondary Endpoints
Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)
Day of study drug administration
ECG (significant abnormalities)
At least 3 times until one day after treatment
Blood pressure
At least 3 times until one day after treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Interventions
NameTypeDescription
Bombesin (68Ga) labeled (BAY86-7548)DRUGCancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
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Eligibility Criteria
Age Range45 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Healthy volunteers: * males, \>/=50 and \</= 65 years of age * Cancer patients: * males \>/= 45 years of age * Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary ...

Countries:FinlandGermanySwitzerland
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