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LY3007113

Phase 1

Metastatic Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Aug 7, 2018

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 Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01463631A Study of LY3007113 in Participants With Advanced CancerPHASE1 COMPLETED 27 — — Dec 1, 2011Dec 1, 2013Aug 7, 20182 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)
Baseline through Study Completion (up to 170 Days)

Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

Secondary Endpoints
The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Baseline through Study Completion (up to 170 Days)
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113
Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours Postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113
Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours Postdose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3007113EXPERIMENTALStudy has a dose escalation phase (Part A) and dose confirmation phase (Part B). Participants in the dose escalation phase will receive 1 of 6 doses of LY3007113 administered orally every 12 hours for at least one cycle. Participants in the dose confirmation phase will receive the maximum tolerated dose from the dose escalation phase administered orally every 12 hours for at least 1 cycle. Three days prior to the start of the first cycle, participants will receive 1 dose at their assigned level to allow for the collection of single dose pharmacokinetics. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Interventions
NameTypeDescription
LY3007113DRUGAdministered orally
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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 for which available standard therapies have failed to provide clinical benefit for their disease * For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma * F...

Countries:United States
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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