NCT00878722

Trial of PXD101 (Belinostat) in Combination With Idarubicin to Treat AML Not Suitable for Standard Intensive Therapy

A Phase I/II Clinical Trial of PXD101 in Combination With Idarubicin in Patients With AML Not Suitable for Standard Intensive Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, non-randomized, multi-centre, Phase I/II trial to assess the efficacy and safety of 2 schedules of PXD101 in combination with idarubicin in patients with AML not suitable for standard intensive therapy.

Detailed description

This trial is an open-label, multi-centre, dose-escalation Phase I/II study to evaluate safety, explore efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with idarubicin administered in two different schedules in patients with AML. The PXD101 plus idarubicin treatment will be repeated at suitable intervals (target is every 3 weeks for schedule A and every 2 weeks for schedule B) depending upon toxicities or disease progression. Safety and efficacy assessments will be performed at every cycle. Schedule A uses PXD101 by 30 min infusion daily for 5 days every 3 weeks with escalating doses of idarubicin. Schedule B uses escalating doses of continuous infusion (48h) of PXD101 alone or in combination with idarubicin. In both regimens the trial may be expanded at the Maximum Tolerated Dose (MTD).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	PXD101
DRUG	idarubicin

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-05-01
• Completion: 2012-04-01
• First posted: 2009-04-09
• Last updated: 2015-07-28
• Results posted: 2014-11-13

Locations

6 sites across 3 countries: France, Germany, United Kingdom