Overview

This trial is active, not recruiting.

Conditions advanced desmoid tumor, advanced chondrosarcoma
Treatment imatinib mesylate
Phase phase 2
Sponsor Italian Sarcoma Group
Start date May 2007
End date December 2016
Trial size 35 participants
Trial identifier NCT00928525, CSTI571 Basket 1, EudraCT Number: 2006-006446-33

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
imatinib mesylate
800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months

Primary Outcomes

Measure
Tumor response will be evaluated by different imaging techniques
time frame: every three months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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).

Additional Information

Official title Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Italian Sarcoma Group.