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)
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).
Inclusion Criteria:
Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
At least one measurable site of disease on CT/MRI scan
Performance status ≤ 2 (capable of self-care but unable to carry out any work)
Normal organ, electrolyte and marrow function
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Flagstaff, Arizona 86001, United States
Duarte, California 91010-3000, United States
Duarte, California 91010-3000, United States
La Jolla, California 92093-0658, United States
Los Angeles, California 90095, United States
Greenwood Village, Colorado, United States
Boston, Massachusetts 02215, United States
Ann Arbor, Michigan 48109-0944, United States
Philadelphia, Pennsylvania 19104-4283, United States
Dallas, Texas 75390-8527, United States
Houston, Texas 77030-4009, United States
San Antonio, Texas 78229, United States
Salt Lake City, Utah 84112, United States
Buenos Aires, Buenos Aires C1264AAA, Argentina
Caba, Buenos Aires C1426ANZ, Argentina
Århus C, DK-8000, Denmark
Saint-Herblain Cédex, 44805, France
Hong Kong SAR, Hong Kong
Sunto-gun, Shizuoka 411-8777, Japan
Chuo-ku, Tokyo 104-0045, Japan
Niaosong Township, Taiwan 83301, Taiwan
Balcova / Izmir, 35340, Turkey (Türkiye)