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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 2/2011

Open Access 01-02-2011 | Original Article

A phase I study of OSI-461 in combination with mitoxantrone in patients with advanced solid tumors potentially responsive to mitoxantrone

Authors: Lee P. Resta, Roberto Pili, Mario A. Eisenberger, Avery Spitz, Serina King, Jennifer Porter, Amy Franke, Ramesh Boinpally, Michael A. Carducci, Christopher J. Sweeney

Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2011

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Abstract

Purpose

To find the maximum tolerated dose (MTD) of OSI-461 in combination with mitoxantrone in patients with advanced solid tumors.

Methods

This was a Phase I study using cohort dose escalation of OSI-461 dosed orally twice daily in combination with mitoxantrone 12 mg/m2 given on Day 1 of each 21-day cycle.

Results

OSI-461 dose was escalated to 1,000 mg po bid. One patient experienced a dose-limiting toxicity (DLT). Three patients discontinued the study due to adverse events (AE). Two patients (10%) had a partial response, and ten patients (50%) had stable disease as best response.

Conclusion

The combination of OSI-461 and mitoxantrone was well tolerated. Dose escalation was stopped because of toxicities in a concurrent Phase I trial. The response rate seen in patients with prostate cancer was comparable to response rates seen in trials of mitoxantrone and prednisone alone, and further studies of the combination of OSI-461 and mitoxantrone were not pursued.
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Metadata
Title
A phase I study of OSI-461 in combination with mitoxantrone in patients with advanced solid tumors potentially responsive to mitoxantrone
Authors
Lee P. Resta
Roberto Pili
Mario A. Eisenberger
Avery Spitz
Serina King
Jennifer Porter
Amy Franke
Ramesh Boinpally
Michael A. Carducci
Christopher J. Sweeney
Publication date
01-02-2011
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 2/2011
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-010-1328-7

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