NCT01149668

A Safety and Tolerability Study of PCI-24781 in Subjects With Cancer

A Long-term Safety Study of the Pan-histone Deacetylase (HDAC) Inhibitor, PCI-24781, in Subjects With Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the long-term (\> 6 months) safety of PCI 24781 PO in subjects with lymphoma.

Detailed description

An open-label, monotherapy, multicenter, extension study open to subjects who have derived benefit from PCI 24781 PO for at least 6 months and want to continue receiving study drug. Subjects enrolled in this study will receive PCI-24781 at the schedule and dosage from their prior protocol. Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

Conditions

• Lymphoma
• Non-Hodgkin's Lymphoma
• Hodgkin Disease
• Multiple Myeloma
• Leukemia
• Lymphocytic

Interventions

Type	Name	Description
DRUG	PCI-24781	Subjects enrolled in this study will receive PCI-24781 administered orally at the schedule and dosage from their prior protocol.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-12-01
• Completion: 2013-04-01
• First posted: 2010-06-23
• Last updated: 2013-06-19

Locations

5 sites across 1 country: United States