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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Motesanib diphosphate; Niacinamide

Criteria

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.