Study to Evaluate Imatinib in Desmoid Tumors

This study is currently recruiting participants.

Verified January 2012 by University of Heidelberg

Sponsor:

Collaborator:

Novartis

Information provided by (Responsible Party):

Bernd Kasper, University of Heidelberg

ClinicalTrials.gov Identifier:

NCT01137916

First received: June 2, 2010

Last updated: January 3, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 2, 2010

Last Updated Date

January 3, 2012

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Non-progression rate after 6 months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01137916 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Non-progression rate after 12 and 24 months of treatment [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Response rate [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Progression-free survival (PFS) and overall survival (OS) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Recording of patient quality of life [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Aggressive Fibromatosis
Desmoid Tumor

Intervention ^ICMJE

Drug: Imatinib

800 mg

Other Name: Glivec

Study Arm (s)

Not Provided

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Peter Hohenberger, Prof.

+49-621-383 ext 2447

peter.hohenberger@umm.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01137916

Other Study ID Numbers ^ICMJE

CSTI571BDE70

Has Data Monitoring Committee

Yes

Responsible Party

Bernd Kasper, University of Heidelberg

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Novartis

Investigators ^ICMJE

Principal Investigator:

Bernd Kasper, PD Dr. med.

University of Heidelberg, Mannheim University Medical Center

Information Provided By

University of Heidelberg

Verification Date

January 2012

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

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