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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Italian Sarcoma Group
ClinicalTrials.gov Identifier:
NCT00928525
First received: June 25, 2009
Last updated: September 9, 2016
Last verified: September 2016
June 25, 2009
September 9, 2016
May 2007
December 2016   (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
Not Provided
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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
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: 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
35
December 2016
December 2016   (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)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00928525
CSTI571 Basket 1
EudraCT Number: 2006-006446-33
Yes
Not Provided
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Prof. Massimo Aglietta, Italian Sarcoma Group
Italian Sarcoma Group
Not Provided
Not Provided
Italian Sarcoma Group
September 2016

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