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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Imatinib Mesylate; Sunitinib

Criteria

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.