Study to Evaluate Imatinib in Desmoid Tumors

Phase 2

Completed

• Conditions: Aggressive Fibromatosis; Desmoid Tumor
• Interventions: Drug: Imatinib

• Registration Number: NCT01137916
• Lead Sponsor: Heidelberg University

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 available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
drug	Imatinib	Imatinib 800 mg

Primary Outcome Measures

Name	Time	Method
Non-progression rate after 6 months of treatment	6 months

Secondary Outcome Measures

Name	Time	Method
Non-progression rate after 12 and 24 months of treatment	12 and 24 months
Response rate	12 and 24 months
Progression-free survival (PFS) and overall survival (OS)	12 and 24 months
Recording of patient quality of life	12 and 24 months

Trial Locations

Locations (1)

University of Heidelberg, Mannheim University Medical Center; 🇩🇪 Mannheim, Germany