NCT00718159

Study of LY573636-sodium in Essential Thrombocythemia and Acute Myeloid Leukemia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Essential Thrombocythemia

Interventions

Type	Name	Description
DRUG	LY573636-sodium	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.

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-07-18
• Last updated: 2019-01-10
• Results posted: 2018-10-16

Locations

5 sites across 1 country: United States