CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
LY573636-sodiumdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00718159
NCT00718159Phase 1Completed

Phase 1 Study of LY573636-sodium in Patients With Essential Thrombocythemia and Acute Myeloid Leukemia

Eli Lilly and Company·interventional·Posted Jul 18, 2008·Updated Jan 10, 2019

In Brief

A Phase 1 clinical trial evaluating LY573636-sodium for Acute Myeloid Leukemia and Essential Thrombocythemia. Completed, enrolled 23 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2008
Enrollment StartAug 1, 2008
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.0 years ago

Interventions

LY573636-sodiumdrug

Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Dosing will be done on Day 1 of a 35-day cycle for acute myeloid leukemia (AML) and Day 1 of a 28-day cycle for essential thrombocythemia (ET) for at least one cycle. A participant may have additional cycles of LY573636 if he or she is receiving benefit from the study drug and does not fulfill any of the criteria for study discontinuation.