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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety
frequency, severity and relatedness of adverse events
30 days after last dose of study drug
Yes
Thorsten Graef, MD
Study Director
Pharmacyclics
United States: Food and Drug Administration
PCYC-0405-CA
NCT01149668
June 2010
April 2013
Name | Location |
---|---|
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 |