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CompletedNCT00928525Basket 1Updated Oct 5, 2023

Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

A Phase 2 interventional study of Imatinib Mesylate in Advanced Desmoid Tumor and Advanced Chondrosarcoma, sponsored by Italian Sarcoma Group. Completed at 7 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Italian Sarcoma Group · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled May 2007, registered Jun 2009).
Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether Imatinib Mesylate is active in diseases - such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived growth factor (PDGF) both in its isoform alpha and beta

02

Conditions studied

  • Advanced Desmoid Tumor
  • Advanced Chondrosarcoma

Keywords

  • PDGFr alpha
  • PDGFr beta
  • KIT
03

In context

Chondrosarcoma

99 studies on the registry are indexed under Chondrosarcoma; 20 are open to participants now.

This study's enrollment of 35 is below the median of 52 across 72 interventional studies indexed under Chondrosarcoma.

Browse Chondrosarcoma studies →

Lead sponsor

Italian Sarcoma Group is the lead sponsor of 31 studies on the registry; 11 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
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

  • Histological diagnosis of DT or CDS.
  • Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRα PDGFRβ activation and/or presence of PDGFα or PDGFβ)
  • Measurable or evaluable disease
  • Surgical resection of local disease unfeasible radically (or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction) and/or disease.
  • Performance status 0, 1, 2 or 3
  • Adequate bone marrow, liver and renal function
  • Female patients of must have negative pregnancy test.
  • Male and female patients of must agree to employ an effective method of throughout the study.
  • Written, voluntary, .

Exclusion criteria

Exclusion Criteria:

  • Previous treatment with any other or not investigational agents within 28 days of first day of study drug dosing
  • Other primary with \<5 years clinically assessed disease-free interval, except basal cell skin cancer or cervical carcinoma in situ.
  • Grade III/IV cardiac problems as defined by the Criteria
  • Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
  • Known .
  • Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
  • Known diagnosis of (HIV) infection.
  • Previous radiotherapy to >/=25% of the bone marrow or within the previous 2 months on target lesion.
  • Major surgery within 2 weeks prior to study entry.
  • Expected non-compliance to medical regimens (e.g. psychiatric diseases).
Terms in these criteria, in plain language(11)

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

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

Study arms

  • Experimental
    Imatinib Mesylate

    Patients affected by Desmoid Tumor and Chondrosarcoma will receive Imatinib Mesylate 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months

    Drug: Imatinib Mesylate

Interventions

06

What researchers measure

Primary outcomes

  1. Tumor response will be evaluated by different imaging techniques

    Time frame: every three months

07

Study locations

7 sites
  • Centro di Riferimento Oncologico - Unit of Medical Oncology
    Aviano, Pordenone 33081, Italy
  • I.R.C.C. - Unit of Medical Oncology
    Candiolo, Torino 10060, Italy
  • Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
    Bologna, 40136, Italy
  • Policlinico S.Orsola Malpighi - Unit of Medical Oncology
    Bologna, 40138, Italy
  • Istituto Nazionale Tumori - Unit of Medical Oncology
    Milano, 20133, Italy
  • Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
    Roma, 00144, Italy
  • Ospedale Gradenigo - Unit of Medical Oncology
    Torino, 10153, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00928525
Lead sponsor
Italian Sarcoma Group
Responsible party
Sponsor
First posted
Jun 26, 2009
Start date
May 2007
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Oct 5, 2023

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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