NCT00684918

Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)

A Multicenter, Open-Label, 2-Stage, Phase II Study of Single-Agent Obatoclax Mesylate Administered For Three Consecutive Days Every 2 Weeks to Older Patients With Previously Untreated Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Gemin X · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.

Detailed description

The Pilot Safety portion of the study will evaluate the safety of obatoclax administered by a 3 hour infusion for 3 days in a row. The Pilot Schedule portion of the study will randomize 16 patients in to one of two cohorts: 1) patients receiving obatoclax administered by a 3 hour infusion for 3 days in a row or 2) patients receiving obatoclax administered by a 24 hour infusion for 3 days in a row. The schedule with the best overall efficacy and safety in the Pilot Schedule portion of the study will then be utilized in the Phase II portion of the study.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Obatoclax	A 3-hour IV infusion for 3 consecutive days or a 24-hour infusion for 3 consecutive days every 2 weeks for up to 6 cycles.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-08-01
• Completion: 2009-12-01
• First posted: 2008-05-28
• Last updated: 2013-08-26

Locations

13 sites across 2 countries: United States, Canada