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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Italian Sarcoma Group Identifier:
First received: June 25, 2009
Last updated: August 22, 2017
Last verified: August 2017
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 Intervention Phase
Advanced Desmoid Tumor Advanced Chondrosarcoma Drug: Imatinib Mesylate Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Prof. Massimo Aglietta, Italian Sarcoma Group:

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

Estimated Enrollment: 35
Study Start Date: May 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00928525

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
  More Information

Responsible Party: Prof. Massimo Aglietta, Professor, Italian Sarcoma Group Identifier: NCT00928525     History of Changes
Other Study ID Numbers: CSTI571 Basket 1
EudraCT Number: 2006-006446-33
Study First Received: June 25, 2009
Last Updated: August 22, 2017

Keywords provided by Prof. Massimo Aglietta, Italian Sarcoma Group:
PDGFr alpha
PDGFr beta

Additional relevant MeSH terms:
Fibromatosis, Aggressive
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Fibrous Tissue
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017