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LY900009

Phase 1

Advanced Cancer | Small molecule | Oncology |Eli Lilly and Company|Trials Updated: Aug 9, 2019

LY900009 target and mechanism

ModalitySmall molecule

Also known as LY900009 - Dose Escalation Phase (Part A)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

LY900009 clinical trials

LY900009 · 1 trial · 1 indication

Phase 1 1
NCT01158404Notch Inhibitor in Advanced CancerAdvanced Cancer
COMPLETED35 Analytics
PHASE1COMPLETED
Notch Inhibitor in Advanced Cancer
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Clinically Significant Effects
Baseline to study completion up to 18.7 weeks

Clinically significant effects are study drug related serious adverse events (SAEs) and study drug related treatment emergent adverse events (TEAEs). A summary of all SAEs and all other non-SAEs regardless of causality is located in the Reported Adverse Events module.

Secondary Endpoints

Recommended Dose Range for Phase 2 Studies
Predose up to 28 days in Cycle 1
Percentage of Participants With a Best Overall Response of Stable Disease or Better (Document the Antitumor Activity)
Baseline to measured progressive disease up to 15.1 weeks
Pharmacokinetics: Area Under the Concentration-time Curve of LY900009 From Time Zero to Infinity [AUC(0-infinity)]
Day1: Pre-dose, 0.5 hours (hr), 1 hr, 3-4 hr, 6-8 hr and 24-30 hours post-dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY900009EXPERIMENTALDose escalation phase: 2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Dose confirmation phase: 30 mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.

Interventions

NameTypeDescription
LY900009 - Dose Escalation Phase (Part A)DRUG2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.
LY900009 - Dose Confirmation Phase (Part B)DRUG30 mg LY900009 orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * The participants must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have ceased to provide clinical benefit for their disease. * The participants must have histological or cytological evidence of c...

Countries:United States
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Competitive Landscape -Cancer 7 trials (matched to "Advanced Cancer")

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Frequently asked questions about LY900009

What is LY900009- Dose Escalation Phase?

LY900009- Dose Escalation Phase is the Phase 1 dose escalation portion of a clinical program evaluating LY900009 in adults with advanced cancer. It is also known as LY900009 - Dose Escalation Phase (Part A). The study enrolled 35 participants in the United States and has been completed.

What is LY900009- Dose Escalation Phase used for in advanced cancer?

LY900009- Dose Escalation Phase was studied in adults with advanced cancer. The trial was an uncontrolled, non-randomized Phase 1 study designed to evaluate the drug in this patient population. No efficacy or approval claims are made here; the program has completed its single listed trial.

Who makes LY900009- Dose Escalation Phase?

LY900009- Dose Escalation Phase is developed by Eli Lilly and Company, which trades under the ticker LLY. Eli Lilly sponsored the Phase 1 trial NCT01158404, titled Notch Inhibitor in Advanced Cancer, which evaluated the drug in participants with advanced cancer.

What phase is LY900009- Dose Escalation Phase in?

LY900009- Dose Escalation Phase is in Phase 1. The single listed trial, NCT01158404, is a completed Phase 1 study with 35 participants. The drug is investigational and has not been approved for any indication based on the available information.

What clinical trials is LY900009- Dose Escalation Phase in?

LY900009- Dose Escalation Phase has been evaluated in one clinical trial: NCT01158404, titled Notch Inhibitor in Advanced Cancer. This Phase 1 trial enrolled 35 adults aged 18 years and older in the United States and is now completed.

Is LY900009- Dose Escalation Phase the same as LY900009 - Dose Escalation Phase (Part A)?

Yes, LY900009- Dose Escalation Phase is also known as LY900009 - Dose Escalation Phase (Part A). The two names refer to the same Phase 1 dose escalation study of LY900009 in advanced cancer, developed by Eli Lilly and Company.