NCT00594230

LBH589 in Refractory Myelodysplastic Syndromes (MDS)

A Phase II Trial of LBH589 in Refractory Myelodysplastic Syndromes (MDS) Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a single arm Phase II study.

Detailed description

LBH589 (20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.

Conditions

• Myelodysplastic Syndromes (MDS)

Interventions

Type	Name	Description
DRUG	Panobinostat	Panobinostat(20 mg or 30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-01-15
• Last updated: 2021-11-22
• Results posted: 2012-12-19

Locations

7 sites across 1 country: United States