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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.
 
ClinicalTrials.gov Identifier: NCT01137916
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bernd Kasper, Heidelberg University

Tracking Information
First Submitted Date  ICMJE June 2, 2010
First Posted Date  ICMJE June 7, 2010
Last Update Posted Date May 3, 2017
Study Start Date  ICMJE June 2010
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2010)
Non-progression rate after 6 months of treatment [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Imatinib in Desmoid Tumors
Official Title  ICMJE 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
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 tumor or disease not readily controllable by surgery or radiotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aggressive Fibromatosis
  • Desmoid Tumor
Intervention  ICMJE Drug: Imatinib
800 mg
Other Name: Glivec
Study Arms  ICMJE Experimental: drug
Imatinib 800 mg
Intervention: Drug: Imatinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2010)
40
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01137916
Other Study ID Numbers  ICMJE CSTI571BDE70
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernd Kasper, Heidelberg University
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Bernd Kasper, PD Dr. med. University of Heidelberg, Mannheim University Medical Center
PRS Account Heidelberg University
Verification Date May 2017

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