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LY2334737

Phase 1

Malignant Solid Tumor | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 17, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

LY2334737 · 1 trial · 3 indications

Phase 1 1
NCT01648764A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has SpreadMalignant Solid Tumor
COMPLETED73 Analytics
PHASE1COMPLETED
A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread
Malignant Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Recommended Dose for Phase 2 Studies
Baseline up to 28 days postdose in Cycle 1 (28-day cycle)

Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). The MTD was the highest dose level at which \<2 out of 6 participants experienced a dose-limiting toxicity (DLT) in Cycle 1. DLT was an adverse event (AE) during Cycle 1 that was likely related to LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥Grade 2 bleeding or Grade 4 thrombocytopenia with or without bleeding; A recovery period longer than 14 days from last dose of LY2334737 to values allowing Cycle 2 to start; Other significant drug-related toxicity deemed by investigator to be dose limiting or that caused the participant to withdraw from the study. Pharmacokinetics and pharmacodynamics (PK/PD) were also taken into consideration for Phase 2 recommended dose.

Secondary Endpoints

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours post dose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours post dose of 28-day cycle
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY2334737 - Arm AEXPERIMENTALLY2334737 administered orally at escalating doses \[40 milligrams (mg) - 200 mg\] every other day for 21 days followed by 7 days without study drug (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met.
LY2334737 - Arm BEXPERIMENTALLY2334737 administered orally at escalating doses (40 mg - 200 mg) every day for 7 days followed by 7 days without study drug then repeated (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met.

Interventions

NameTypeDescription
LY2334737DRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Diagnosis of advanced and/or metastatic cancer (including lymphoma) for which no treatment of higher priority exists * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Estimated life expectancy of more than 12 weeks * Have discontinued all previous therapies ...

Countries:United StatesFranceGermany
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Frequently asked questions about LY2334737

What is LY2334737 used for?

LY2334737 is an investigational small molecule being studied for the treatment of malignant solid tumors, including solid tumors that are advanced and/or have spread (metastatic). It is being developed by Eli Lilly and Company for use in oncology.

Who makes LY2334737?

LY2334737 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule intended for the treatment of malignant solid tumors.

What phase is LY2334737 in?

LY2334737 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is no longer in active clinical trials.

What clinical trials is LY2334737 in?

LY2334737 has been studied in one clinical trial, NCT01648764, titled 'A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread.' This Phase 1 trial was completed and enrolled 73 participants with malignant solid tumors, including metastatic tumors.

Is LY2334737 the same as any other drug?

LY2334737 is the only name provided for this investigational drug. No alternative names have been reported for this compound, which is being developed by Eli Lilly and Company for the treatment of malignant solid tumors.