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LY2584702

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

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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Frequently asked questions about LY2584702

What is LY2584702 used for?

LY2584702 is an investigational small molecule being studied for the treatment of cancer and for use in healthy participants. It was evaluated in Phase 1 clinical trials, including a study in patients with solid tumors and a single-dose study in healthy participants to assess safety and absorption.

Who makes LY2584702?

LY2584702 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is an investigational small molecule that has been studied in early-stage clinical trials for oncology and healthy participant indications.

What phase is LY2584702 in?

LY2584702 is in Phase 1 clinical development. It has completed two Phase 1 trials: one in patients with solid tumors in Japan and another in healthy participants in Singapore. The drug is investigational and not approved for any use.

What clinical trials is LY2584702 in?

LY2584702 has been studied in two completed Phase 1 trials. NCT01241461 evaluated the drug in patients with solid tumors in Japan, enrolling 9 participants. NCT01372085 was a single-dose study in healthy participants in Singapore, enrolling 29 participants. Both trials are completed.

How does LY2584702 work?

LY2584702 is a small molecule being investigated for its potential anti-cancer activity. Its specific molecular target has not been disclosed in the available clinical trial information. The drug was studied in a Phase 1 trial for solid tumors and in a healthy participant study to evaluate its safety and absorption.