NCT01702155

Phase I/II Study of DFP-10917 in Patients With Acute Leukemia

A Phase I/II Study of DFP 10917 Given by Continuous Infusion in Patients With Relapsed or Refractory Acute Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Delta-Fly Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of DFP-10917 given via continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL).

Detailed description

This study will determine the safety and efficacy of DFP-10917 in patients with AML or ALL. The Phase I dose-escalation portion of the study will determine the highest tolerable dose and regimen (7 or 14 day continuous infusion) based on safety data in patients with refractory or relapsed AML or ALL. The phase II portion will investigate the safety and efficacy of DFP-10917, at the dose and regimen to be determined in the Phase I portion, in patients with refractory or relapsed AML.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	DFP-10917

Timeline

• Start date: 2012-10-10
• Primary completion: 2017-01-18
• Completion: 2017-10-11
• First posted: 2012-10-05
• Last updated: 2019-10-25

Locations

1 site across 1 country: United States