Activity of Sorafenib in Salivary Gland Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Sorafenib in Recurrent and/or Metastatic Salivary Gland Carcinomas: Phase II Study|
- Objective response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Response Rate according to RECIST criteria. Response will be evaluated every 2 months.
- safety [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]number of patients with adverse events
- response rate according to CHOI criteria [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- correlation between CHOI criteria and outcome [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||January 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|