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
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- 作者：Marije Slingerland (1) m.slingerland@lumc.nl
Hans Gelderblom (1) - 关键词：Campthotecin – ; Colorectal cancer – ; Phase II – ; BAY 56 ; 3722
- 刊名：Investigational New Drugs
- 出版年：2012
- 出版时间：June 2012
- 年：2012
- 卷：30
- 期：3
- 页码：1208-1210
- 全文大小：83.1 KB
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8. http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf - 作者单位：1. Department of Clinical Oncology, Leiden University Medical Center, Albinusdreef 2, 2300 RC Leiden, The Netherlands
- 刊物类别：Medicine
- 刊物主题：Medicine & Public Health
Oncology
Pharmacology and Toxicology - 出版者：Springer Netherlands
- ISSN：1573-0646
文摘
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/m2 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.