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NCT00718159 · ClinicalTrials.gov registry record · Phase 1
Study of LY573636-sodium in Essential Thrombocythemia and Acute Myeloid Leukemia
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00718159: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT00718159 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00718159, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to determine a safe dose of LY573636-sodium to be given to patients with acute myeloid leukemia and to determine any side effects that may be associated with LY573636-sodium in this patient population. Efficacy measures will also be used to assess the activity of LY573636-sodium in acute myeloid leukemia and essential thrombocythemia patients.
Primary Outcome
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose at which no more than 1 of 6 participants experienced a dose-limiting toxicity (DLT) and level immediately below that which had ≥2 instances of DLT. A DLT is an adverse event (AE) observed during the first cycle of treatment that is believed to be related to LY573636 and fulfills any of the following: ET only , Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity
Interventions
- DRUG LY573636-sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT00718159 record still lists
NCT00718159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which LY573636-sodium is the first listed.
NCT00718159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00718159 about?
NCT00718159 is a clinical study titled "Study of LY573636-sodium in Essential Thrombocythemia and Acute Myeloid Leukemia". The purpose of this study is to determine a safe dose of LY573636-sodium to be given to patients with acute myeloid leukemia and to determine any side effects that may be associated with LY573636-sodium in this patient population. Efficacy measures will also be used to assess the activity of LY57363...
What is the current status of trial NCT00718159?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2008-08. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00718159?
The interventions under investigation include: LY573636-sodium (DRUG).
Who is sponsoring clinical trial NCT00718159?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00718159's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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