Study to Evaluate Imatinib in Desmoid Tumors

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01137916

First Posted: June 7, 2010

Last Update Posted: May 3, 2017

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.

Collaborator:

Novartis

Information provided by (Responsible Party):

Bernd Kasper, Heidelberg University

Purpose

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	Intervention	Phase
Aggressive Fibromatosis Desmoid Tumor	Drug: Imatinib	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: desmoid tumor

Drug Information available for: Imatinib Imatinib mesylate

Genetic and Rare Diseases Information Center resources: Desmoid Tumor

U.S. FDA Resources

Further study details as provided by Bernd Kasper, Heidelberg University:

Primary Outcome Measures:

Non-progression rate after 6 months of treatment [ Time Frame: 6 months ]

Secondary Outcome Measures:

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 ]


Enrollment:	39
Study Start Date:	June 2010
Study Completion Date:	December 2016
Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: drug Imatinib 800 mg	Drug: Imatinib 800 mg Other Name: Glivec

Eligibility

Information from the National Library of Medicine

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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

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

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 Submitted:	June 2, 2010
First Posted:	June 7, 2010
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

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