Study to Evaluate Imatinib in Desmoid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137916
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):
Bernd Kasper, Heidelberg University

June 2, 2010
June 7, 2010
May 3, 2017
June 2010
December 2016   (Final data collection date for primary outcome measure)
Non-progression rate after 6 months of treatment [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01137916 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Study to Evaluate Imatinib in Desmoid Tumors
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
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Aggressive Fibromatosis
  • Desmoid Tumor
Drug: Imatinib
800 mg
Other Name: Glivec
Experimental: drug
Imatinib 800 mg
Intervention: Drug: Imatinib
Kasper B, Gruenwald V, Reichardt P, Bauer S, Hohenberger P, Haller F. Correlation of CTNNB1 Mutation Status with Progression Arrest Rate in RECIST Progressive Desmoid-Type Fibromatosis Treated with Imatinib: Translational Research Results from a Phase 2 Study of the German Interdisciplinary Sarcoma Group (GISG-01). Ann Surg Oncol. 2016 Jun;23(6):1924-7. doi: 10.1245/s10434-016-5132-4. Epub 2016 Feb 9.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Bernd Kasper, Heidelberg University
Heidelberg University
Principal Investigator: Bernd Kasper, PD Dr. med. University of Heidelberg, Mannheim University Medical Center
Heidelberg University
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP