Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT00089960
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00089960
Study Brief:
Protocol Section:
NCT00089960