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Data from an anticancer agent’s phase III trial that was suspended due to increased mortality has been presented at an annual meeting of experts in America.
The trial started in March 2005 and was conducted in 69 sites in North America and Europe. In May 2007, after an analysis of 210 patients, the US Food and Drug Administration (FDA) placed the trial on clinical hold due to increased mortality. The area of concern was in the arm of the study looking at cytarabine in combination with cloretazine in patients with first relapse of acute myelogenous leukaemia – as compared to the cytarabine plus placebo control arm.
In January 2008, Vion Pharmaceuticals announced that the FDA had lifted the clinical hold and that a new trial with a lower dose of cloretazine could be pursued in the future.
The 44th Annual Meeting of the American Society of Clinical Oncology in Chicago, Illinois, heard the on-study mortality was 39% for the cytarabine and cloretazine treatment arm versus 9% for the control arm.
Alan Kessman, Chief Executive Officer at Vion, said although the trial was discontinued for safety reasons, he believed the combination merited further evaluation in first relapse of AML with modifications to “address the observed toxicity and mortality at the studied dose and schedule”.
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