Novartis discontinues clinical trial of Tasigna for investigational use in newly diagnosed patients with unresectable and/or metastatic GIST
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Novartis announced it is discontinuing a Phase III trial of Tasigna® (nilotinib) for investigational use in the first-line treatment of gastrointestinal stromal tumors (GIST) based on the recommendation of an independent data monitoring committee. Interim results showed Tasigna is unlikely to demonstrate superiority compared to Glivec® (imatinib), the current standard of care in this setting.
The trial is a randomized, open-label, multicenter study evaluating the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable and/or metastatic GIST. The side effect profile seen in this trial was consistent with previous studies of Tasigna.
Novartis is committed to further advancing treatment options for patients with GIST and continues to explore studies for these patients.