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The fate of camptothecin glycoconjugate: report of a clinical hold during a phase II study of BAY 56-3722 (formerly BAY 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan
Introduction BAY 56-3722 (formerly BAY 38-3441) is a glycoconjugated campthotecin, which was considered an attractive drug to assess in colorectal cancer (CRC). Patient and methods Phase II study design evaluating the antitumor activity of BAY 56-3722 IV 320 mg/m(2) daily for 3 days every 3 weeks in...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer US
2011
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3348469/ https://www.ncbi.nlm.nih.gov/pubmed/21547368 http://dx.doi.org/10.1007/s10637-011-9679-4 |
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author | Slingerland, Marije Gelderblom, Hans |
author_facet | Slingerland, Marije Gelderblom, Hans |
author_sort | Slingerland, Marije |
collection | PubMed |
description | Introduction BAY 56-3722 (formerly BAY 38-3441) is a glycoconjugated campthotecin, which was considered an attractive drug to assess in colorectal cancer (CRC). Patient and methods Phase II study design evaluating the antitumor activity of BAY 56-3722 IV 320 mg/m(2) daily for 3 days every 3 weeks in patients with recurrent or metastatic inoperable CRC resistant to irinotecan. Results Twenty-four patients received the study treatment. Triggered by adverse events in two other studies with this compound the study was put on a clinical hold while the safety data were reviewed for the entire program. After the review Bayer decided to withdraw BAY 56-3722 from all clinical investigations. Discussion We felt it was our obligation to share this interrupted phase II study for two reasons: to report the fate of camptothecin glycoconjugate and to report the unique situation of a clinical hold during a phase II study. |
format | Online Article Text |
id | pubmed-3348469 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-33484692012-05-30 The fate of camptothecin glycoconjugate: report of a clinical hold during a phase II study of BAY 56-3722 (formerly BAY 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan Slingerland, Marije Gelderblom, Hans Invest New Drugs Phase II Studies Introduction BAY 56-3722 (formerly BAY 38-3441) is a glycoconjugated campthotecin, which was considered an attractive drug to assess in colorectal cancer (CRC). Patient and methods Phase II study design evaluating the antitumor activity of BAY 56-3722 IV 320 mg/m(2) daily for 3 days every 3 weeks in patients with recurrent or metastatic inoperable CRC resistant to irinotecan. Results Twenty-four patients received the study treatment. Triggered by adverse events in two other studies with this compound the study was put on a clinical hold while the safety data were reviewed for the entire program. After the review Bayer decided to withdraw BAY 56-3722 from all clinical investigations. Discussion We felt it was our obligation to share this interrupted phase II study for two reasons: to report the fate of camptothecin glycoconjugate and to report the unique situation of a clinical hold during a phase II study. Springer US 2011-05-06 2012 /pmc/articles/PMC3348469/ /pubmed/21547368 http://dx.doi.org/10.1007/s10637-011-9679-4 Text en © The Author(s) 2011 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. |
spellingShingle | Phase II Studies Slingerland, Marije Gelderblom, Hans The fate of camptothecin glycoconjugate: report of a clinical hold during a phase II study of BAY 56-3722 (formerly BAY 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan |
title | The fate of camptothecin glycoconjugate: report of a clinical hold during a phase II study of BAY 56-3722 (formerly BAY 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan |
title_full | The fate of camptothecin glycoconjugate: report of a clinical hold during a phase II study of BAY 56-3722 (formerly BAY 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan |
title_fullStr | The fate of camptothecin glycoconjugate: report of a clinical hold during a phase II study of BAY 56-3722 (formerly BAY 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan |
title_full_unstemmed | The fate of camptothecin glycoconjugate: report of a clinical hold during a phase II study of BAY 56-3722 (formerly BAY 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan |
title_short | The fate of camptothecin glycoconjugate: report of a clinical hold during a phase II study of BAY 56-3722 (formerly BAY 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan |
title_sort | fate of camptothecin glycoconjugate: report of a clinical hold during a phase ii study of bay 56-3722 (formerly bay 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan |
topic | Phase II Studies |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3348469/ https://www.ncbi.nlm.nih.gov/pubmed/21547368 http://dx.doi.org/10.1007/s10637-011-9679-4 |
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