ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Aggressive Fibromatosis Desmoid Tumor Drug: Imatinib Phase 2

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: drug
Imatinib 800 mg
 Drug: Imatinib
800 mg
Other Name: Glivec


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Non-progression rate after 6 months of treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Non-progression rate after 12 and 24 months of treatment [ Time Frame: 12 and 24 months ]
  2. Response rate [ Time Frame: 12 and 24 months ]
  3. Progression-free survival (PFS) and overall survival (OS) [ Time Frame: 12 and 24 months ]
  4. Recording of patient quality of life [ Time Frame: 12 and 24 months ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137916


Locations
Germany
University of Heidelberg, Mannheim University Medical Center
Mannheim, Germany, 68167
Sponsors and Collaborators
Heidelberg University
Novartis
Investigators
Principal Investigator: Bernd Kasper, PD Dr. med. University of Heidelberg, Mannheim University Medical Center
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Bernd Kasper, PD Dr. med., Heidelberg University
ClinicalTrials.gov Identifier: NCT01137916     History of Changes
Other Study ID Numbers: CSTI571BDE70
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Aggression
Fibromatosis, Aggressive
Fibroma
Behavioral Symptoms
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action