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LY900009- Dose Escalation Phase

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

LY900009- Dose Escalation Phase · 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 5 trials (matched to "Advanced Cancer")

Frequently asked questions about LY900009- Dose Escalation Phase

What is LY900009 used for?

LY900009 is an investigational small molecule being studied for the treatment of advanced cancer. It is a Notch inhibitor that was evaluated in a Phase 1 clinical trial in patients with advanced cancer. The drug is not approved and remains in clinical development.

What does LY900009 target?

LY900009 targets the Notch signaling pathway, which is involved in cell differentiation and proliferation. By inhibiting Notch, the drug aims to interfere with cancer cell growth. This mechanism was the focus of its Phase 1 trial in advanced cancer.

Who makes LY900009?

LY900009 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company conducted a Phase 1 clinical trial of the drug in patients with advanced cancer.

What phase is LY900009 in?

LY900009 is in Phase 1 clinical development. A Phase 1 trial of the drug in advanced cancer has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is LY900009 in?

LY900009 has been studied in one clinical trial, identified as NCT01158404, titled 'Notch Inhibitor in Advanced Cancer.' This Phase 1 trial enrolled 35 participants with advanced cancer in the United States and has been completed.

Is LY900009 the same as a Notch inhibitor?

LY900009 is a Notch inhibitor, meaning it works by blocking the Notch signaling pathway. This mechanism was evaluated in a Phase 1 clinical trial for advanced cancer. The drug is being developed by Eli Lilly and Company.