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LY3007113

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

LY3007113 · 1 trial · 1 indication

Phase 1 1
NCT01463631A Study of LY3007113 in Participants With Advanced CancerMetastatic Cancer
COMPLETED27 Analytics
PHASE1COMPLETED
A Study of LY3007113 in Participants With Advanced Cancer
Metastatic CancerUnlock trial analytics

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 to 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 (matched to "Metastatic Cancer")

Frequently asked questions about LY3007113

What is LY3007113 used for?

LY3007113 is an investigational small molecule being studied for the treatment of metastatic cancer. It was evaluated in a Phase 1 clinical trial in participants with advanced cancer. The drug is not approved and remains in clinical development.

Who makes LY3007113?

LY3007113 is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company sponsored a Phase 1 clinical trial of the drug in patients with advanced cancer.

What phase is LY3007113 in?

LY3007113 is in Phase 1 clinical development. A single Phase 1 trial of the drug has been completed. The drug is investigational and has not been approved for any use.

What clinical trials is LY3007113 in?

LY3007113 has been studied in one clinical trial, NCT01463631, titled "A Study of LY3007113 in Participants With Advanced Cancer." This Phase 1 trial was completed in the United States and enrolled 27 participants with metastatic cancer.

Is LY3007113 FDA approved?

LY3007113 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The drug is still in clinical development and has not been authorized for marketing.