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PET tracer

Phase 1

Neoplasms | Small molecule | Oncology |Lantheus Holdings, Inc.|Last Updated: Nov 13, 2014

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01186601Exploration of Tumor Accumulation of BAY94-9392 in Patients With CancerPHASE1 COMPLETED 30Dec 1, 2010Oct 1, 2011Nov 13, 20141 United States
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Study Endpoints
Primary Endpoints
Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.
Day 1
Evaluation of the accumulation of BAY94-9392 in known or suspected local and/or systemic recurrent cancer lesions and/or lymph node metastasis or distant metastasis.
Day 1
Secondary Endpoints
Standardized uptake value (SUV)
Day 1
Standardized uptake value ratio (SUVR)
Day 1
Vital Signs
Day 1 and Day 2
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
PET tracer (BAY94-9392)DRUGA radioactive dose of 300 MBq of the study drug with a total quantity of \</= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males/females \>/= 18 years * Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis ar...

Countries:United States
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