A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : imatinib (STI571)
- drug : Nilotinib (AMN107)
Phase: Phase 3
Ages Eligible For Study:
1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either: - have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or - recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies. 2. At least one measurable site of disease on CT/MRI scan 3. Performance status ? 2 (capable of self-care but unable to carry out any work) 4. Normal organ, electrolyte and marrow function