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news.Eli Lilly has terminated its global Phase III study evaluating Tasisulam, an investigational, small-molecule anti-cancer compound, as a second-line treatment for those with unresectable or metastatic melanoma.
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Lilly, in consultation with an independent data monitoring committee, recommended a ‘full clinical hold,’ because of safety concerns.
Following the declaration of clinical hold no new or existing patients in the trial receive additional doses of the compound, allowing researchers the time to fully analyse existing data.
Lilly notified regulatory agencies and contacted all trial investigators to provide details on how to manage individuals enrolled in the trial.
Lilly Oncology Product Development and Medical Affairs vice president Richard Gaynor said that they 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.