Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

A Single-arm, Open-label, Multi-center, Phase Iv, Efficacy And Safety Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Gastrointestinal Stromal Tumor After Disease Progression On Or Intolerance To Imatinib Mesylate

To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.

Inclusion Criteria:

• Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).
• Evidence of unidimensionally measurable disease
• Failure of prior treatment with imatinib or intolerant to imatinib
• Male or female, 18 years of age or older.
• ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
• Resolution of all acute toxic effects
• Adequate organ function.

Exclusion Criteria:

• Anticancer treatment after last dose of imatinib
• Major surgery within 4 weeks or radiation therapy within 2 weeks.
• Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.
• Diagnosis of second malignancy within the last 5 years.
• History of brain disease.
• Cardiac disease within 12 months.
• Thyroid function abnormality.
• Ongoing cardiac dysrhythmias.
• Uncontrolled hypertension.
• Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.
• HIV or AIDS related illness.
• Pregnancy or breastfeeding.