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LY2624587

Phase 1

Metastatic Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jan 24, 2012

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 Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01139788A Study of LY2624587 in Patients With Advanced CancerPHASE1 COMPLETED 56Jun 1, 2010Nov 1, 2011Jan 24, 20122 United States
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Study Endpoints
Primary Endpoints
Recommended dose for Phase 2 studies
Baseline to study completion
Secondary Endpoints
Number of participants with clinically significant effects
Baseline to cycle 12
Radiological tumor measurement
Baseline, Cycle 1 Day-1, Cycle 2 - Day 1, Cycle 3 - Day 1
Pharmacokinetics of LY2624587, area under the concentration-time curve (AUC)
Cycle 1 - Cycle 12
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY2624587EXPERIMENTAL -
Interventions
NameTypeDescription
LY2624587DRUG6-900 mg, administered intravenously, weekly for a minimum of one (1) 28 day cycle. If patients are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Present with histological or cytological evidence of a diagnosis of cancer (solid tumors, lymphoma, or chronic lymphocytic leukemia) that is advanced and/or metastatic. The patient must be, in the judgement of the investigator, an appropriate candidate for experimental therapy...

Countries:United States
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