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A Study of Nilotinib Versus Imatinib in GIST Patients
Trial ID: NCT00785785
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
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)
1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and
- 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
1. Any prior anti-neoplastic therapy with the exception of patients who have received
adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose
disease requires therapy while awaiting entry to the study.
2. Disease progression during adjuvant therapy with imatinib
3. History of active malignancy (other than GIST) within 10 years prior to study entry
with the exception of previous or concomitant basal cell skin cancer, previous
cervical carcinoma in situ.
4. Impaired cardiac function
Other protocol-defined inclusion/exclusion criteria may apply
drug: Nilotinib (AMN107)
drug: imatinib (STI571)
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Cancer Clinical Trials Office