Evaluation of the safety and efficacy of Imatinib in Pat. with Desmoid-Tumors

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000624-40-DE

Enrollment

Registered

2010-03-02

Start date

2010-05-27

Completion date

Unknown

Last updated

2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AGGRESSIVE FIBROMATOSIS / DESMOID TUMORS

Interventions

Trade Name: Glivec Product Name: Glivec Pharmaceutical Form: Coated tablet INN or Proposed INN: IMATINIB MESILATE CAS Number: 220127-57-1 Other descriptive name: Glivec Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion 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 >= 18 years • WHO PS ==65 years) yes F.1.3.1 Number of subjects for this age range 37

Exclusion criteria

Exclusion criteria: • Surgical intervention = 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 • Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the activity of imatinib and nilotinib in AF patients with relapsing disease after the standard therapy.;Secondary Objective: Evaluation of the safety of imatinib and nilotinitb in AF patients with relapsing disease after the standard therapy.;Primary end point(s): Non-progression rate after 6 months of treatment;Timepoint(s) of evaluation of this end point: 6 month after start of treatmen	—

Measure

Time frame

Main Objective: Evaluation of the activity of imatinib and nilotinib in AF patients with relapsing disease after the standard therapy.;Secondary Objective: Evaluation of the safety of imatinib and nilotinitb in AF patients with relapsing disease after the standard therapy.;Primary end point(s): Non-progression rate after 6 months of treatment;Timepoint(s) of evaluation of this end point: 6 month after start of treatmen

—

Secondary

Measure	Time frame
Secondary end point(s): non-progression rate after 12 and 24 months of treatment response rate (complete remission (CR), partial remission (PR), stable disease (SD) > 12 weeks Progression-free survival (PFS) and overall survival (OS) Tolerability of the treatment Toxic effects recording of patient quality of liefe according to the Toronto Extremity Salvage Score (TESS) at study baseline and end of study visit;Timepoint(s) of evaluation of this end point: 12 months after treatment 24 months after treatment	—

Measure

Time frame

Secondary end point(s): non-progression rate after 12 and 24 months of treatment response rate (complete remission (CR), partial remission (PR), stable disease (SD) > 12 weeks Progression-free survival (PFS) and overall survival (OS) Tolerability of the treatment Toxic effects recording of patient quality of liefe according to the Toronto Extremity Salvage Score (TESS) at study baseline and end of study visit;Timepoint(s) of evaluation of this end point: 12 months after treatment 24 months after treatment

—

Countries

Germany

Contacts

Public ContactBernd Kasper

University of Heidelberg, Medical Faculty Mannheim,

bernd.kasper@umm.de496213832580

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026