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Imatinib in Patients With Desmoid Tumor and Chondrosarcoma (Basket 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00928525
Recruitment Status : Active, not recruiting
First Posted : June 26, 2009
Last Update Posted : August 23, 2017
Information provided by (Responsible Party):

June 25, 2009
June 26, 2009
August 23, 2017
May 2007
December 2017   (Final data collection date for primary outcome measure)
Tumor response will be evaluated by different imaging techniques [ Time Frame: every three months ]
Same as current
Complete list of historical versions of study NCT00928525 on ClinicalTrials.gov Archive Site
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Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
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
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced Desmoid Tumor
  • Advanced Chondrosarcoma
Drug: Imatinib Mesylate
800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months
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
Intervention: Drug: Imatinib Mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
December 2017
December 2017   (Final data collection date for primary outcome measure)

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 metastatic disease.
  • ECOG Performance status 0, 1, 2 or 3
  • Adequate bone marrow, liver and renal function
  • Female patients of child-bearing potential must have negative pregnancy test.
  • Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
  • Written, voluntary, informed consent.

Exclusion Criteria:

  • Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing
  • Other primary malignancy 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 New York Heart Association Criteria
  • Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
  • Known brain metastasis.
  • Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
  • Known diagnosis of human immunodeficiency virus (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).
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CSTI571 Basket 1
EudraCT Number: 2006-006446-33
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Prof. Massimo Aglietta, Italian Sarcoma Group
Italian Sarcoma Group
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Not Provided
Italian Sarcoma Group
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP