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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00150072 |
Preliminary response data, observed by Casali (Cancer, 2004) with imatinib 800 mg/day in patients affected by chordoma, need to be confirmed by a Phase II study, whose primary endpoint will be the formal assessment of clinical and pathological response. Aim of the study will be to explore treatment's activity, but also the potential impact of tumor response, the feasibility and outcome of subsequent surgery and radiotherapy. In addition, patterns of tumour response need to be investigated as well, given the peculiar patterns of response shown with molecular-targeted therapy in solid tumors.
Condition | Intervention | Phase |
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Chordoma |
Drug: imatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Phase II Study of Imatinib Mesylate in Chordoma |
Enrollment: | 55 |
Study Start Date: | October 2004 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: imatinib |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Debulking surgery before enrolment is allowed. In this case, enrolment should occur at least one month after surgery
Exclusion Criteria:
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CSTI571BIT15 |
Study First Received: | September 7, 2005 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00150072 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
chordoma imatinib PDGFR |
Imatinib Neoplasms, Germ Cell and Embryonal Protein Kinase Inhibitors Chordoma |
Imatinib Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Germ Cell and Embryonal Enzyme Inhibitors Protein Kinase Inhibitors Chordoma Pharmacologic Actions |