Date: 2011-04-11
Type of information: Initiation of preclinical development
phase: 3
Announcement: discontinued study
Company: Novartis (Switzerland)
Product: Tasigna® (nilotinib)
Action
mechanism: signal transduction inhibitor of the Bcr-Abl kinase, c-kit and Platelet Derived Growth Factor (PDGF), all of which play a role in cell proliferation, cell migration, and angiogenesis.
Disease: first-line treatment of gastrointestinal stromal tumors
Therapeutic area: Cancer - Oncology
Country:
Trial
details: 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®. ENESTg1 (Evaluating Nilotinib Efficacy and Safety in Clinical Trials Versus Imatinib in Adult Patients With Unresectable and/or Metastatic GIST) began in 2009 in centers across the world with the goal of recruiting more than 700 GIST patients. These patients were newly diagnosed with unresectable and/or metastatic GIST and were not permitted to receive any prior cancer therapies other than adjuvant Glivec®. The trial\'s primary endpoint was a comparison of progression-free survival between Tasigna® and Glivec® when used as initial therapy in these patients.
Latest
news: 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.
