Sorafenib in recurrent and/or metastatic salivary gland carcinomas - ND

Conditions: advanced/metastatic disease
MedDRA version: 9.1Level: SOCClassification code 10029104
MedDRA version: 9.1Level: HLTClassification code 10029105

Registration Number: EUCTR2010-020375-24-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Histologically proven relapsed and/or metastatic salivary gland cancer for which potentially curative options such as surgery or radiotherapy are not indicated. 2. Subjects with at least one uni-dimensional measurable lesion by CT-scan or MRI according to RECIST criteria (target lesion). A previously treated lesion by radiotherapy can be chosen as target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry 2. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Response Rate according to RECIST criteria. Response will be evaluated every 2 months.;Secondary Objective: Response rate according to CHOI criteria Correlation between CHOI criteria and outcome Disease Control Rate (DCR) Acute toxicity according to CTC-AE v 3;Primary end point(s): Response Rate according to RECIST criteria. Response will be evaluated every 2 months.

Secondary Outcome Measures