Activity of Sorafenib in Salivary Gland Cancer
This trial is active, not recruiting.
|Condition||salivary gland cancer|
|Targets||RAF, FLT-3, KIT, PDGF, VEGF|
|Sponsor||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|
|Start date||September 2010|
|End date||October 2012|
|Trial size||37 participants|
|Trial identifier||NCT01703455, INT29/10|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 8 weeks
time frame: 4 weeks
response rate according to CHOI criteria
time frame: 8 weeks
correlation between CHOI criteria and outcome
time frame: one year
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - Symptomatic metastatic brain or meningeal tumors - History of cardiac disease such as congestive heart failure>NYHA class 2 - Active CAD - Cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension - Pregnant or breast-feeding patient - Patients with evidence or history of bleeding diathesis - Patients undergoing renal dialysis - Patients unable to swallow oral medication
|Official title||Sorafenib in Recurrent and/or Metastatic Salivary Gland Carcinomas: Phase II Study|
Call for more information