Recent Updates
Recently added Catalysts

LY2780301

Phase 1

Metastases, Neoplasm | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jul 31, 2012

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01115751A Study in Patients With Advanced or Metastatic CancerPHASE1 COMPLETED 80Mar 1, 2010Jul 1, 2012Jul 31, 20122 Spain
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Recommended dose for Phase 2 Studies
Baseline to study completion
Secondary Endpoints
Clinically significant effects
Baseline to study completion
Pharmacokinetics, area under the concentration-time curve
Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
Best overall response (CR+PR+SD)
Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY2780301EXPERIMENTALPart A: daily dosing Part B (if determined as needed by pharmacokinetic, pharmacodynamic, and safety data): twice daily dosing Part C: Dose and frequency as determined by Parts A and B of the study.
Interventions
NameTypeDescription
LY2780301DRUGAdministered orally, daily for two 28-day cycles. Starting dose is 100mg. The dose will be subsequently increased to 200mg, 300mg, 400mg, 500mg, and 600mg if no dose limiting toxicity is observed at the prior dose levels. Patients who, in the opinion of the investigator, demonstrate clinical benefit may receive treatment beyond two cycles until disease progression.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (including Non-Hodgkin's Lymphoma). The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therap...

Countries:Spain
Unlock Eligibility Criteria