This trial is active, not recruiting.

Conditions aggressive fibromatosis, desmoid tumor
Treatment imatinib
Phase phase 2
Sponsor Heidelberg University
Collaborator Novartis
Start date June 2010
End date February 2016
Trial size 40 participants
Trial identifier NCT01137916, CSTI571BDE70


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 tumor or disease not readily controllable by surgery or radiotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Imatinib 800 mg
imatinib Glivec
800 mg

Primary Outcomes

Non-progression rate after 6 months of treatment
time frame: 6 months

Secondary Outcomes

Non-progression rate after 12 and 24 months of treatment
time frame: 12 and 24 months
Response rate
time frame: 12 and 24 months
Progression-free survival (PFS) and overall survival (OS)
time frame: 12 and 24 months
Recording of patient quality of life
time frame: 12 and 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study to Evaluate Glivec (Imatinib Mesylate) to Induce Progression Arrest in Aggressive Fibromatosis / Desmoid Tumors Not Amenable to Surgical Resection With R0 Intent or Accompanied by Unacceptable Function Loss
Principal investigator Bernd Kasper, PD Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Heidelberg University.