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NCT01214655 · ClinicalTrials.gov registry record · Phase 1

A Study for Patients With Acute Leukemia

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

Terminated
Registry status
Phase 1
Development phase
33
Enrollment target

NCT01214655: Clinical Trial Phase 1 study, sponsored by Eli Lilly and Company.

NCT01214655 is a Phase 1 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01214655, a Phase 1 study, was terminated before completion, sponsored by Eli Lilly and Company.

TERMINATED
Registry status
Phase 1
Development phase
33 participants
Enrollment target

Study Summary

This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to participants with acute leukemia. Part A and Part B are dose escalation of two schedules in participants with acute leukemia. Parts A and B will enroll concurrently. Part C is a dose expansion for each schedule in participants with acute myeloblastic leukemia (AML).

Primary Outcome

The recommended dose and schedule for Phase 2 studies of LY2523355 with acute leukemia was determined by a modification of the continual reassessment method. The sample size to adequately determine the maximum tolerated dose (MTD) for both schedules in this study was a function of a priori estimates for the dose-toxicity relationship as well as the initial dose in each schedule, the rate of dose escalation, and the observed dose-toxicity relationship. Before MTD could be determined for Part B (D

Interventions

  • DRUG LY2523355

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2008-06
Est. Completion 2011-02
Phase Phase 1
Eli Lilly and Company

1,341 total trials

Why NCT01214655 stopped before completion

NCT01214655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).

The record links to 0 conditions, and to 1 intervention - of which LY2523355 is the first listed.

NCT01214655 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01214655 about?

NCT01214655 is a clinical study titled "A Study for Patients With Acute Leukemia". This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to participants with acute leukemia. Part A and Part B are dose escalation of two sche...

What is the current status of trial NCT01214655?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2008-06. Estimated completion is 2011-02.

What interventions are being tested in trial NCT01214655?

The interventions under investigation include: LY2523355 (DRUG).

Who is sponsoring clinical trial NCT01214655?

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 NCT01214655's enrollment target sits among peer trials

33 1280th of 2000 higher than 705 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 NCT01214655, the US trial registry maintained by the National Library of Medicine. NCT01214655 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.