A Long-term Safety Study of the Pan-histone Deacetylase (HDAC) Inhibitor, PCI-24781, in Subjects With Cancer
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
frequency, severity and relatedness of adverse events
30 days after last dose of study drug
Thorsten Graef, MD
United States: Food and Drug Administration
|Nebraska Methodist Hospital||Omaha, Nebraska 68114|
|Sarah Cannon Research Institute||Nashville, Tennessee 37203|
|Horizon Oncology Center||Lafayette, Indiana 47905|
|Northwestern Univ. Med School||Chicago, Illinois 60611|
|Univ. of Nebraska Medical Center||Omaha, Nebraska 68198|