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| Sponsor: | Italian Sarcoma Group |
|---|---|
| Information provided by: | Italian Sarcoma Group |
| ClinicalTrials.gov Identifier: | NCT00928525 |
Purpose
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 II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma |
| Estimated Enrollment: | 35 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Giovanni Grignani, MD | +39.011.9933 ext 278 | ggrignani@mauriziano.it |
| Contact: Manuela Muliello, SC | +39.011.9933 ext 278 | mmuliello@mauriziano.it |
| Italy | |
| Centro di Riferimento Oncologico - Unit of Medical Oncology | Recruiting |
| Aviano, Pordenone, Italy, 33081 | |
| Contact: Sergio Frustaci, MD sfrustaci@cro.it | |
| Contact: Angela Buonadonna, MD abuonadonna@cro.it | |
| Principal Investigator: Sergio Frustaci, MD | |
| Sub-Investigator: Angela Buonadonna, MD | |
| I.R.C.C. - Unit of Medical Oncology | Recruiting |
| Candiolo, Torino, Italy, 10060 | |
| Contact: Giovanni Grignani, MD +39.011.9933 ext 278 ggrignani@mauriziano.it | |
| Contact: Manuela Muliello, SC +39.011.9933 ext 278 mmuliello@mauriziano.it | |
| Sub-Investigator: Giovanni Grignani, MD | |
| Principal Investigator: Massimo Aglietta, MD | |
| Policlinico S.Orsola Malpighi - Unit of Medical Oncology | Recruiting |
| Bologna, Italy, 40138 | |
| Contact: Guido Biasco, MD guido.biasco@unibo.it | |
| Contact: Monica Di Battista, MD monica.dibattista@tin.it | |
| Principal Investigator: Guido Biasco, MD | |
| Sub-Investigator: Monica Di Battista, MD | |
| Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors | Recruiting |
| Bologna, Italy, 40136 | |
| Contact: Stefano Ferrari, MD stefano.ferrari@ior.it | |
| Contact: Emanuela Palmerini, MD emanuela.palmerini@ior.it | |
| Principal Investigator: Stefano Ferrari, MD | |
| Sub-Investigator: Emanuela Palmerini, MD | |
| Istituto Nazionale Tumori - Unit of Medical Oncology | Recruiting |
| Milano, Italy, 20133 | |
| Contact: Paolo Casali, MD Paolo.Casali@istitutotumori.mi.it | |
| Contact: Silvia Stacchiotti, MD Silvia.Stacchiotti@istitutotumori.mi.it | |
| Principal Investigator: Paolo Casali, MD | |
| Sub-Investigator: Silvia Stacchiotti, MD | |
| Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I | Recruiting |
| Roma, Italy, 00144 | |
| Contact: Francesco Cognetti, MD cognetti@ifo.it | |
| Contact: Virginia Ferraresi, MD ferraresi@ifo.it | |
| Principal Investigator: Francesco Cognetti, MD | |
| Sub-Investigator: Virginia Ferraresi, MD | |
| Ospedale Gradenigo - Unit of Medical Oncology | Recruiting |
| Torino, Italy, 10153 | |
| Contact: Alessandro Comandone, MD alessandro.comandone@h-gradenigo.it | |
| Contact: Alessandra Boglione, MD alessandra.boglione@h-gradenigo.it | |
| Principal Investigator: Alessandro Comandone, MD | |
| Sub-Investigator: Alessandra Boglione, MD | |
More Information
| Responsible Party: | Prof. Massimo Aglietta, AO Ordine Mauriziano |
| ClinicalTrials.gov 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: | July 27, 2009 |
| Health Authority: | Italy: Ministry of Health; Italy: AIFA (Agenzia Italiana del FArmaco) - Osservatorio per le Sperimentaziooni Cliniche |
|
PDGFr alpha PDGFr beta KIT |
|
Chondrosarcoma Fibromatosis, Aggressive Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Fibroma |
Neoplasms, Fibrous Tissue Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |