Status:
COMPLETED
Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)
Lead Sponsor:
Amgen
Conditions:
Gastrointestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.
Detailed Description
Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00089960
Start Date
October 1 2004
End Date
June 1 2008
Last Update
April 29 2013
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