NCT00776503

Vorinostat and Low Dose Cytarabine for High Risk Myelodysplasia

A Phase I/II Study of Vorinostat in Combination With Low Dose Ara-C for Patients With Intermediate-2 or High Risk Myelodysplastic Syndromes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated duration and schedule of oral VORINOSTAT in addition to low dose cytarabine in the treatment of Intermediate-2 and High risk myelodysplastic syndromes.

Detailed description

This is a multi-center, open-label, non-randomized, Phase I/II study. Patients will be treated either with arm A or B dosing schedules which contain increasing durations of exposure to vorinostat. LD Ara-C will be administered once daily, subcutaneously(SC), at 10 mg/m² in Cycle 1 and escalated to 20 mg/m² daily in Cycle 2 and above for 14 out of 28 days. Oral vorinostat will be administered as 400 mg, once daily either sequentially(Arm A) or concurrently (Arm B) with LD Ara-C in Dose Level #1 for 7 days, Dose Level #2 for 10 days, or Dose Level #3 for 14 days out of each 28-day cycle. Patients who do not have disease progression and who continue to meet eligibility criteria may receive up to 3 additional 28-day cycles of treatment.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	VORINOSTAT	vorinostat; 400mg once daily; increasing duration (7-10-14 days)

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2008-10-21
• Last updated: 2014-03-20

Locations

14 sites across 1 country: France