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Clinical Trial
. 2012 Jun;30(3):1208-10.
doi: 10.1007/s10637-011-9679-4. Epub 2011 May 6.

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

Marije Slingerland  1 , Hans Gelderblom
Affiliations
Clinical Trial

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

Marije Slingerland et al. Invest New Drugs. 2012 Jun.

Abstract

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 i.v. 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.

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