Study to Evaluate Imatinib in 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

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01137916

Enrollment

Registered

2010-06-07

Start date

2010-06-30

Completion date

2016-12-31

Last updated

2017-05-03

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

Conditions

Aggressive Fibromatosis, Desmoid Tumor

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.

Interventions

DRUGImatinib

800 mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Non-progression rate after 6 months of treatment	6 months

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026