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Study to Evaluate Imatinib in Desmoid Tumors

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bernd Kasper, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01137916
First received: June 2, 2010
Last updated: May 2, 2017
Last verified: May 2017
June 2, 2010
May 2, 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 ClinicalTrials.gov 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
Interventional
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
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, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01137916
CSTI571BDE70
Yes
Not Provided
Not Provided
Bernd Kasper, Heidelberg University
Heidelberg University
Novartis
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