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NCT01158404 · ClinicalTrials.gov registry record · Phase 1

Notch Inhibitor in Advanced Cancer

A Phase 1 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 1
Development phase
35
Enrollment target

NCT01158404: Completed Phase 1 study, sponsored by Eli Lilly and Company.

NCT01158404 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01158404, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 1
Development phase
35 participants
Enrollment target

Study Summary

The objective of this phase 1 study is to evaluate the safety and tolerability of Notch Inhibitor in participants with advanced cancer. This study includes dose escalation and dose confirmation components.

Primary Outcome

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.

Interventions

  • DRUG LY900009 - Dose Escalation Phase (Part A)
  • DRUG LY900009 - Dose Confirmation Phase (Part B)

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2010-07
Est. Completion 2012-08
Phase Phase 1
Eli Lilly and Company

1,341 total trials

What the finished NCT01158404 record still lists

NCT01158404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 2 interventions - of which LY900009 - Dose Escalation Phase (Part A) is the first listed.

NCT01158404 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01158404 about?

NCT01158404 is a clinical study titled "Notch Inhibitor in Advanced Cancer". The objective of this phase 1 study is to evaluate the safety and tolerability of Notch Inhibitor in participants with advanced cancer. This study includes dose escalation and dose confirmation components.

What is the current status of trial NCT01158404?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2010-07. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01158404?

The interventions under investigation include: LY900009 - Dose Escalation Phase (Part A) (DRUG), LY900009 - Dose Confirmation Phase (Part B) (DRUG).

Who is sponsoring clinical trial NCT01158404?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01158404's enrollment target sits among peer trials

35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01158404, the US trial registry maintained by the National Library of Medicine. NCT01158404 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.