Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)

An Open Label Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate

This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.

Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.

Inclusion Criteria

• Age ≥ 18 years;
• Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) during previous treatment with imatinib mesylate at least 600 mg daily for at least 8 weeks, as per two independently assessed prestudy computerized tomography (CT) scans;
• Presence of at least one measurable (per RECIST)
• Progressing tumor lesion not previously treated with radiotherapy or embolization and evaluable by CT scan or magnetic resonance imaging (MRI);
• Karnofsky performance status ≥ 60;
• imatinib treatment terminated at least 7 days before study day 1;
• Adequate hepatic, renal, and cardiac function.

Exclusion criteria:

• Prior malignancy (other than GIST, in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years; cardiac disease including myocardial infarction, unstable angina, and congestive heart failure (New York Heart Association class > II),
• uncontrolled hypertension (systolic > 145 mmHg or diastolic > 85 mmHg),
• History of arterial thrombosis or deep vein thrombosis (including pulmonary embolus) within 1 year of study day 1;
• Absolute neutrophil count < 1.5x109/L, platelet count < 100x109/L, hemoglobin < 9.0 g/dL;
• Prior treatment with motesanib diphosphate or other KIT (except imatinib) or VEGF inhibitors.
• The study was approved by the institutional review board of each participating institution, and all patients provided written informed consent before any study-related procedures were performed.