This trial is active, not recruiting.

Condition salivary gland cancer
Treatment sorafenib
Phase phase 2
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Objective response
time frame: 8 weeks

Secondary Outcomes

time frame: 4 weeks
response rate according to CHOI criteria
time frame: 8 weeks
correlation between CHOI criteria and outcome
time frame: one year

Eligibility Criteria

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

Additional Information

Official title Sorafenib in Recurrent and/or Metastatic Salivary Gland Carcinomas: Phase II Study
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.