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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT01137916
Eligibility Criteria:
Inclusion Criteria:
* Patients with histological confirmed aggressive fibromatosis (desmoid tumor)
* Measurable disease according to the RECIST criteria
* Evidence of relapse or disease progression within the last 6 months (based on RECIST criteria) in computed tomography or magnetic resonance imaging
* No possibility of complete surgical resection or cases in which surgical therapy leaving a large tissue defect, functional deficit or disfigurement would be required
* No possibility of curative radiotherapy with acceptable toxicity and/or late morbidity
* Previous treatment of the tumor region by surgical intervention and/or radiotherapy and/or antihormonal therapy possible
* Age \> or = 18 years
* WHO PS \< or = 1
* Effective contraception during study medication
* Signed informed consent form
Exclusion Criteria:
* Surgical intervention \< 4 weeks
* Prior therapy with imatinib
* Pregnancy or lactation
* Severe hepatic dysfunction
* Known allergic reaction to imatinib or one of its components
* The following laboratory values: Absolute neutrophil count \< 1.5 x 103/mm3, Platelets \< 100,000/mm3, Serum creatinine \> or = 2.5 mg/dl, SGOT and/or SGPT \> 2.5 x ULN (upper limit of normal), Total bilirubin \> 1.5 x ULN
* Participation in another study (four weeks before and during the study)
* Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01137916
Study Brief:
Protocol Section:
NCT01137916