Article > Lilly suspends melanoma trial after deaths: "Eli Lilly has suffered a setback with the news that it has stopped a late-stage clinical trial of its investigational skin cancer drug tasisulam after 12 study participants died.
The company has suspended its global Phase III study evaluating tasisulam as a second-line treatment for patients with unresectable or metastatic melanoma. Lilly, in consultation with an independent data monitoring committee, has recommended a 'full clinical hold,' because of safety concerns. The trial sought to compare tasisulam versus paclitaxel and enrolled more than 300 patients in 18 countries; its primary endpoint is overall survival.
Now the company is going to see whether the 12 deaths are in any way related to treatment with tasisulam. Richard Gaynor, head of oncology product development and medical affairs for Lilly, said “we are thoroughly reviewing the clinical trial data to understand what modifications to the study protocol or dosing would be needed to improve patient safety on this trial”.
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