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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00359333
Eligibility Criteria:
Inclusion Criteria:
* 5.1.1 Patients must have a histologically confirmed diagnosis of (1) locally advanced unresectable or metastatic soft tissue sarcoma; or (2) unresectable/metastatic GIST previously treated with imatinib mesylate and is documented to have drug resistance to imatinib mesylate treatment defined by tumor progression.
5.1.2 Age greater than or equal to 18 years and younger than or equal to 70 years old.
5.1.3 Measurable disease: defined as lesions that can be measured in at least one dimension by physical examination or medical imaging techniques. Ascites, pleural effusions, and bone marrow disease will not considered measurable disease.
5.1.4 Patients must have an ECOG performance status of less than or equal to 2. 5.1.5 Patients must have recovered (defined as toxicity less than grade 2) from toxic effects of all prior therapy before entering onto study.
5.1.6 A treatment of drug free interval of at least 4 weeks since the last dose of chemotherapy or imatinib mesylate therapy is required.
5.1.7 More than 4 weeks since prior radiotherapy is required. 5.1.8 Adequate bone marrow function with an ANC greater than or equal to 1,500/ml, platelet count greater than or equal to 100,000/ ml (transfusion independent) and hemoglobin greater than or equal to 8.0 g/dl (transfusions permitted).
5.1.9 Patients must have adequate renal function with serum creatinine less than or equal to 1.5 mg/dl.
5.1.10 Patients must have adequate liver function, defined as bilirubin within 1.5 times the upper limit of normal, and liver transaminases within 2.5 times the upper limit of normal.
5.1.11 All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study.
Exclusion Criteria:
* 5.2.1 Patients who have prior treatment with gemcitabine or taxane. 5.2.2 Pregnant or breast feeding females. 5.2.3 Active or uncontrolled infection. 5.2.4 Patients with brain or leptomeningeal metastases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00359333
Study Brief:
Protocol Section:
NCT00359333