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CompletedNCT02495519Updated Jan 14, 2020

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

A Phase 2 interventional study of Imatinib in Fibromatosis, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by Yonsei University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
10 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Fibromatosis

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03

In context

Fibroma

19 studies on the registry are indexed under Fibroma; 4 are open to participants now.

This study's enrollment of 21 is below the median of 62 across 13 interventional studies indexed under Fibroma.

Browse Fibroma studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Other co-existing 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    imatinib

    Imatinib 400 mg/day until disease progression

    Drug: Imatinib

Interventions

  • Imatinib 400 mg/day until disease progression

06

What researchers measure

Primary outcomes

  1. non-progressive rate

    non-progressive rate at 16weeks

    Time frame: 16weeks

Secondary outcomes

  1. overall survival

    Time frame: 16 weeks

07

Study locations

1 site
  • Severance Hospital, Yonsei University Health System
    Seoul, 120-752, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02495519
Lead sponsor
Yonsei University
Responsible party
Hyo Song Kim (Clinical Associate Professor, Yonsei University) — Principal investigator
First posted
Jul 13, 2015
Start date
Apr 2014
Primary completion
Jun 2018
Completion
Jun 2018
Last update
Jan 14, 2020

Study contacts

Hyo Song Kim
principal investigator · Severance Hospital, Yonsei University Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Imatinib

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