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ClinicalTrials.gov Identifier: NCT01703455
Recruitment Status : Unknown
Verified January 2013 by Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Recruitment status was: Active, not recruiting
First Posted : October 10, 2012
Last Update Posted : January 30, 2013
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Information provided by (Responsible Party):
Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
This is a single agent, prospective, open-label, monocenter, phase II trial of sorafenib in patients with recurrent and/or metastatic salivary gland carcinoma. This trial will be conducted with the primary aim to determine the response rate (CR+PR) according to the RECIST criteria. Response rate according to CHOI criteria, correlation between CHOI criteria and outcome, disease Control Rate (DCR) and acute toxicity will be evaluated as secondary objectives.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically proven relapsed and/or metastatic salivary gland cancer for which potentially curative options such as surgery or radiotherapy are not indicated
One target lesion measurable by CT-scan or MRI according to RECIST criteria
Age + 18 years
ECOG 0 or 1
Adequate bone marrow, liver and renal function
Signed written informed consent
Symptomatic metastatic brain or meningeal tumors
History of cardiac disease such as congestive heart failure>NYHA class 2
Cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension
Pregnant or breast-feeding patient
Patients with evidence or history of bleeding diathesis