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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020375-24-IT

Enrollment

Registered

2010-07-16

Start date

2010-08-11

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced/metastatic disease MedDRA version: 9.1 Level: SOC Classification code 10029104 MedDRA version: 9.1 Level: HLT Classification code 10029105

Interventions

Trade Name: NEXAVAR Pharmaceutical Form: Capsule, hard INN or Proposed INN: SORAFENIB TOSILATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026