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

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Trial Identification

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

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

Study ID: NCT00878722

Interventions

PXD101
idarubicin

Study Description

Brief 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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHU Lapeyronie, Montpellier, , France

Hôpital St. Louis, Paris, , France

Uniklinik Homburg, Homburg, , Germany

Uni Hospital Marburg, Marburg, , Germany

Universitätsklinikum Ulm, Ulm, , Germany

Christie Hospital NHS Trust, Manchester, , United Kingdom

Contact Details

Name: e-mail contact via enquiries@topotarget.com

Affiliation: Valerio Therapeutics

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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