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:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT00367861
Eligibility Criteria:
Inclusion Criteria:
1. Patients 18 years of age or over.
2. Histologically documented diagnosis of malignant GIST.
3. Immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases using the DAKO assay.
4. Performance status 0,1, 2, 3 (ECOG)
5. Adequate end organ function, defined as the following: total bilirubin \< 1.5 x ULN, SGOT and SGPT \< 2.5 x UNL (or \< 5 x ULN if hepatic metastases are present), creatinine \< 1.5 x ULN, ANC \> 1.0 x 109/L, platelets \> 100 x 109/L.
6. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 2 weeks (according to updated Invest. Brochure) following discontinuation of study drug.
7. Written, voluntary, informed consent.
Exclusion Criteria:
1. Patient has another malignant tumor in CR\<3 years (except if the other primary malignancy is inactive and not requiring active intervention). Previous basal cell skin cancer or a cervical carcinoma in situ are allowed.
2. Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
3. Female patients who are pregnant or breast-feeding.
4. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
5. Patients received chemotherapy within 2 weeks prior to study entry, unless the disease is rapidly progressing
6. Patients had a major surgery within 2 weeks prior to entry study
7. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
8. Previous treatment with Glivec®
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00367861
Study Brief:
Protocol Section:
NCT00367861