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Phase I Trials

Bortezomib Alone and in Combination With Standard Chemotherapies

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Proteasome Inhibitors in Cancer Therapy

Part of the book series: Cancer Drug Discovery and Development ((CDD&D))

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Abstract

The Phase I development of the proteasome inhibitor, bortezomib (formerly known as PS-341), in patients with advanced cancer began in 1998. Since that time clinical trials have studied both single agent bortezomib and bortezomib in combination with other chemotherapy agents. The side effect profile that has emerged from dose escalation trials suggests manageable toxicities. Gastrointestinal side effects such as diarrhea and nausea were dose-related and peripheral sensory neuropathy was dose-limiting in some patients with solid tumors. Indications of efficacy in multiple myeloma (including a durable complete remission), non-Hodgkin’s lymphoma, and selected solid tumors were also reported. The recommended dose and schedule for Phase II development was 1.3 mg/m2/ dose given twice weekly for 2 wk with 10 d rest.

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Authors
  1. Dixie-Lee W. Esseltine
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  2. David P. Schenkein
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Editor information

Editors and Affiliations

  1. Infinity Pharmaceuticals Inc., Cambridge, MA, USA

    Julian Adams PhD

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© 2004 Springer Science+Business Media New York

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Esseltine, DL.W., Schenkein, D.P. (2004). Phase I Trials. In: Adams, J. (eds) Proteasome Inhibitors in Cancer Therapy. Cancer Drug Discovery and Development. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59259-794-9_20

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  • DOI: https://doi.org/10.1007/978-1-59259-794-9_20

  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-61737-452-4

  • Online ISBN: 978-1-59259-794-9

  • eBook Packages: Springer Book Archive

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