A Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

A Phase II Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02495519

Enrollment

Registered

2015-07-13

Start date

2014-04-30

Completion date

2018-06-30

Last updated

2020-01-14

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

Conditions

Fibromatosis

Brief summary

Aggressive fibromatosis (AF, also known as desmoid tumor) is a fibroproliferative neoplasm that typically arises in the abdomen but can develop at other anatomic sites, most commonly in the extremities. These tumors have a relatively high local failure rate after primary treatment using surgery and/or radiotherapy, and although rarely giving rise to distant metastases, can be multifocal and, therefore, not surgically resectable. Moreover, tumor may recur adjacent to the site of surgical resection, underscoring the limitations of surgery in the palliative setting. Therefore, effective medical therapies for AF are needed to maintain quality of life and prolong survival.The goal of the current study was to better define the activity of imatinib in the treatment of AF and to determine the molecular basis for response/nonresponse

Interventions

DRUGImatinib

Imatinib 400 mg/day until disease progression

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Written consent; 2. Age ≥ 10 years; 3. Eastern Cooperative Oncology Group Performance status ≤ 2; 4. Histologically confirmed desmoid tumor; 5. Disease progression after local treatment 6. Measurable target lesion (RECIST criteria) ; 7. Adequate hematological, renal and liver functions :

Exclusion criteria

1. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 2. Pregnant or lactating female 3. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Design outcomes

Primary

Measure	Time frame	Description
non-progressive rate	16weeks	non-progressive rate at 16weeks

Secondary

Measure	Time frame
overall survival	16 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026