Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma

Paul Richardson, Constantine Mitsiades, Kathleen Colson, Eileen Reilly, Laura McBride, Judy Chiao, Linda Sun, Justin Ricker, Syed Rizvi, Carol Oerth, Barbara Atkins, Ivy Fearen, Kenneth Anderson, David Siegel

Research output: Contribution to journalArticle

159 Citations (Scopus)

Abstract

A Phase I trial (NCT00109109) of oral vorinostat 200, 250 or 300 mg twice daily for 5 days/week/4-week cycle or 200, 300, or 400 mg twice daily for 14 days/3-week cycle until progressive disease or intolerable toxicity was conducted. Patients with measurable, relapsed/refractory multiple myeloma were eligible. The objectives were to determine maximum tolerated doses (MTDs) and assess activity and safety. Thirteen patients (median age, 63 years; median prior therapies, 3) were enrolled. MTDs were not determined due to early study termination by sponsor decision. One patient (250 mg twice daily 5 days/week) developed dose-limiting toxicity (DLT; grade 3 fatigue). There were no other DLTs and the maximum administered doses were 250 mg twice daily for 5 days/week/ 4-week cycle and 200 mg twice daily for 14 days/3-week cycle. Drug-related adverse experiences included fatigue, anorexia, dehydration, diarrhea, and nausea and were mostly grade ≤2. Of 10 evaluable patients, 1 had a minimal response and 9 had stable disease, demonstrating modest single-agent activity in relapsed/refractory multiple myeloma.

Original languageEnglish (US)
Pages (from-to)502-507
Number of pages6
JournalLeukemia and Lymphoma
Volume49
Issue number3
DOIs
StatePublished - Mar 1 2008

Fingerprint

Multiple Myeloma
Maximum Tolerated Dose
Fatigue
Anorexia
Dehydration
Nausea
Diarrhea
Safety
vorinostat
Pharmaceutical Preparations
Therapeutics

Keywords

  • Histone deacetylase inhibitor
  • Multiple myeloma
  • SAHA
  • Suberoylanilide hydroxamic acid
  • Vorinostat
  • Zolinza

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Richardson, P., Mitsiades, C., Colson, K., Reilly, E., McBride, L., Chiao, J., ... Siegel, D. (2008). Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma. Leukemia and Lymphoma, 49(3), 502-507. https://doi.org/10.1080/10428190701817258

Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma. / Richardson, Paul; Mitsiades, Constantine; Colson, Kathleen; Reilly, Eileen; McBride, Laura; Chiao, Judy; Sun, Linda; Ricker, Justin; Rizvi, Syed; Oerth, Carol; Atkins, Barbara; Fearen, Ivy; Anderson, Kenneth; Siegel, David.

In: Leukemia and Lymphoma, Vol. 49, No. 3, 01.03.2008, p. 502-507.

Research output: Contribution to journalArticle

Richardson, P, Mitsiades, C, Colson, K, Reilly, E, McBride, L, Chiao, J, Sun, L, Ricker, J, Rizvi, S, Oerth, C, Atkins, B, Fearen, I, Anderson, K & Siegel, D 2008, 'Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma', Leukemia and Lymphoma, vol. 49, no. 3, pp. 502-507. https://doi.org/10.1080/10428190701817258
Richardson, Paul ; Mitsiades, Constantine ; Colson, Kathleen ; Reilly, Eileen ; McBride, Laura ; Chiao, Judy ; Sun, Linda ; Ricker, Justin ; Rizvi, Syed ; Oerth, Carol ; Atkins, Barbara ; Fearen, Ivy ; Anderson, Kenneth ; Siegel, David. / Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma. In: Leukemia and Lymphoma. 2008 ; Vol. 49, No. 3. pp. 502-507.
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