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LY2584702

Phase 1

Cancer | Small molecule | Oncology |Eli Lilly and Company|Trials Updated: Aug 21, 2018

LY2584702 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since May 2010

LY2584702 target and mechanism

Molecular targetRPS6KB1
Target classInhibitor
ModalitySmall molecule

Also known as LY2584702 Reference Formulation

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

LY2584702 clinical trials

LY2584702 · 1 trial · 1 indication

Phase 1 1
NCT01241461A Study of LY2584702 in Solid TumorsCancer
COMPLETED9 Analytics
PHASE1COMPLETED
A Study of LY2584702 in Solid Tumors
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Clinically Significant Effects
Baseline through 30 days

A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count \<50.0 x 10\^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count \<0.5 x 10\^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity.

Secondary Endpoints

Number of Participants With Tumor Response
Baseline to study completion up to Day 183
Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2584702
Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2584702
Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY2584702EXPERIMENTAL -

Interventions

NameTypeDescription
LY2584702DRUGDose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle. Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists. * Have the presence of disease amena...

Countries:Japan
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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about LY2584702

What is LY2584702?

LY2584702 is an investigational small molecule developed by Eli Lilly and Company for the treatment of cancer. It is a kinase inhibitor that has been studied in solid tumors. It is also referred to as LY2584702 Reference Formulation. The compound is in Phase 1 clinical development and has not been approved for any indication.

What does LY2584702 target?

LY2584702 targets RPS6KB1, also known as p70S6 kinase, an enzyme involved in cell growth and protein synthesis signaling. LY2584702 acts as an inhibitor of this target. Inhibiting RPS6KB1 is the proposed mechanism by which the compound is intended to affect tumor cell signaling in cancer.

Who makes LY2584702?

LY2584702 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating the compound in oncology. The drug remains an investigational agent and is not a marketed product.

What phase is LY2584702 in?

LY2584702 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 program has been conducted in patients with solid tumors, and the single listed trial has completed.

What clinical trials is LY2584702 in?

LY2584702 has been evaluated in one Phase 1 trial, NCT01241461, titled A Study of LY2584702 in Solid Tumors. That trial enrolled 9 participants in Japan, included patients aged 20 years and older of any sex, and is now completed. It was an uncontrolled study without randomization or blinding.

Is LY2584702 the same as LY2584702 Reference Formulation?

Yes. LY2584702 Reference Formulation is an alternative name for LY2584702, the small molecule RPS6KB1 inhibitor developed by Eli Lilly and Company. Both names refer to the same investigational oncology compound. Searches for either name point to the same Phase 1 solid tumor program.