NCT01214655

A Study for Patients With Acute Leukemia

Phase 1 Study of LY2523355 in Patients With Acute Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Leukemia

Interventions

Type	Name	Description
DRUG	LY2523355	Administered as a 1-hour IV infusion for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-10-05
• Last updated: 2019-05-13
• Results posted: 2019-05-13

Locations

5 sites across 1 country: United States