Status:
COMPLETED
Study to Evaluate Imatinib in Desmoid Tumors
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Novartis
Conditions:
Aggressive Fibromatosis
Desmoid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01137916
Start Date
June 1 2010
End Date
December 1 2016
Last Update
May 3 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Heidelberg, Mannheim University Medical Center
Mannheim, Germany, 68167