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Originally published as JCO Early Release 10.1200/JCO.2005.14.167 on May 16 2005

Journal of Clinical Oncology, Vol 23, No 17 (June 10), 2005: pp. 3923-3931
© 2005 American Society of Clinical Oncology.
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Phase I Study of an Oral Histone Deacetylase Inhibitor, Suberoylanilide Hydroxamic Acid, in Patients With Advanced Cancer

William Kevin Kelly, Owen A. O'Connor, Lee M. Krug, Judy H. Chiao, Mark Heaney, Tracy Curley, Barbara MacGregore-Cortelli, William Tong, J. Paul Secrist, Lawrence Schwartz, Stacy Richardson, Elaina Chu, Semra Olgac, Paul A. Marks, Howard Scher, Victoria M. Richon

From the Genitourinary Oncology Service, Lymphoma and Developmental Chemotherapy Service, Thoracic Oncology Service, Leukemia Service, Departments of Medicine, Nursing, Epidemiology and Biostatistics, Radiology, Pathology; Cell Biology Program of Sloan-Kettering Institute, Memorial Sloan-Kettering Cancer Center and Joan and Sanford Weill Medical College of Cornell University, New York, NY

Address reprint requests to William Kevin Kelly, DO, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; e-mail: kellyw{at}mskcc.org.

PURPOSE: To determine the safety, dosing schedules, pharmacokinetic profile, and biologic effect of orally administered histone deacetylase inhibitor suberoylanilide hydroxamic acid (SAHA) in patients with advanced cancer.

PATIENTS AND METHODS: Patients with solid and hematologic malignancies were treated with oral SAHA administered once or twice a day on a continuous basis or twice daily for 3 consecutive days per week. Pharmacokinetic profile and bioavailibity of oral SAHA were determined. Western blots and enzyme-linked immunosorbent assays of histones isolated from peripheral-blood mononuclear cells (PBMNCs) pre and post-therapy were performed to evaluate target inhibition.

RESULTS: Seventy-three patients were treated with oral SAHA and major dose-limiting toxicities were anorexia, dehydration, diarrhea, and fatigue. The maximum tolerated dose was 400 mg qd and 200 mg bid for continuous daily dosing and 300 mg bid for 3 consecutive days per week dosing. Oral SAHA had linear pharmacokinetics from 200 to 600 mg, with an apparent half-life ranging from 91 to 127 minutes and 43% oral bioavailability. Histones isolated from PBMNCs showed consistent accumulation of acetylated histones post-therapy, and enzyme-linked immunosorbent assay demonstrated a trend towards a dose-dependent accumulation of acetylated histones from 200 to 600 mg of oral SAHA. There was one complete response, three partial responses, two unconfirmed partial responses, and 22 (30%) patients remained on study for 4 to 37+ months.

CONCLUSIONS: Oral SAHA has linear pharmacokinetics and good bioavailability, inhibits histone deacetylase activity in PBMNCs, can be safely administered chronically, and has a broad range of antitumor activity.

Supported by the National Institutes of Health: CA96228-0 (W.K.K.); CaPCURE, PepsiCo Foundation, The DeWitt Wallace Fund for Memorial Sloan-Kettering Cancer Center, The Kleberg Foundation, David Koch Foundation and Aton Pharma, Inc, a wholly owned subsidiary of Merck & Co Inc. O.A.O. is the recipient of the Research Scholar Award from the Leukemia and Lymphoma Society.

Parts of this manuscript have been presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003; and at the American Association for Respiratory Care–National Cancer Institute–European Organisation for Research and Treatment of Cancer International Conference: Molecular Targets and Cancer Therapeutics, Frankfurt, Germany, November 19-22, 2002, and Boston, MA, November 17-21, 2003.

Terms in blue are defined in the glossary, found at the end of this issue and online at www.jco.org.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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A. Munshi, T. Tanaka, M. L. Hobbs, S. L. Tucker, V. M. Richon, and R. E. Meyn
Vorinostat, a histone deacetylase inhibitor, enhances the response of human tumor cells to ionizing radiation through prolongation of {gamma}-H2AX foci.
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S. E. Bates, D. R. Rosing, T. Fojo, and R. L. Piekarz
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Histone Deacetylase Inhibitors Repress the Transactivation Potential of Hypoxia-inducible Factors Independently of Direct Acetylation of HIF-{alpha}
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M. Sankaranarayanapillai, W. P. Tong, D. S. Maxwell, A. Pal, J. Pang, W. G. Bornmann, J. G. Gelovani, and S. M. Ronen
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R. W. Robey, Z. Zhan, R. L. Piekarz, G. L. Kayastha, T. Fojo, and S. E. Bates
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 JCOHome page
O. A. O'Connor, M. L. Heaney, L. Schwartz, S. Richardson, R. Willim, B. MacGregor-Cortelli, T. Curly, C. Moskowitz, C. Portlock, S. Horwitz, et al.
Clinical Experience With Intravenous and Oral Formulations of the Novel Histone Deacetylase Inhibitor Suberoylanilide Hydroxamic Acid in Patients With Advanced Hematologic Malignancies
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Y. Zhao, J. Tan, L. Zhuang, X. Jiang, E. T. Liu, and Q. Yu
Inhibitors of histone deacetylases target the Rb-E2F1 pathway for apoptosis induction through activation of proapoptotic protein Bim
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O. A. O'Connor
Targeting Histones and Proteasomes: New Strategies for the Treatment of Lymphoma
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W.-S. Xu, G. Perez, L. Ngo, C.-Y. Gui, and P. A. Marks
Induction of Polyploidy by Histone Deacetylase Inhibitor: A Pathway for Antitumor Effects
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