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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. Identifier: NCT00928525
Recruitment Status : Unknown
Verified April 2018 by Prof. Massimo Aglietta, Italian Sarcoma Group.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2009
Last Update Posted : April 19, 2018
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Italian Sarcoma Group

Brief 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

Condition or disease Intervention/treatment Phase
Advanced Desmoid Tumor Advanced Chondrosarcoma Drug: Imatinib Mesylate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
Actual Study Start Date : May 2007
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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
800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months

Primary Outcome Measures :
  1. Tumor response will be evaluated by different imaging techniques [ Time Frame: every three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00928525

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Centro di Riferimento Oncologico - Unit of Medical Oncology
Aviano, Pordenone, Italy, 33081
I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, Italy, 10060
Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
Policlinico S.Orsola Malpighi - Unit of Medical Oncology
Bologna, Italy, 40138
Istituto Nazionale Tumori - Unit of Medical Oncology
Milano, Italy, 20133
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
Roma, Italy, 00144
Ospedale Gradenigo - Unit of Medical Oncology
Torino, Italy, 10153
Sponsors and Collaborators
Italian Sarcoma Group
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Responsible Party: Prof. Massimo Aglietta, Professor, Italian Sarcoma Group Identifier: NCT00928525    
Other Study ID Numbers: CSTI571 Basket 1
EudraCT Number: 2006-006446-33
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Keywords provided by Prof. Massimo Aglietta, Italian Sarcoma Group:
PDGFr alpha
PDGFr beta
Additional relevant MeSH terms:
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Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Fibrous Tissue
Fibromatosis, Aggressive
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action