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Activity of Sorafenib in Salivary Gland Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01703455
Recruitment Status : Unknown
Verified January 2013 by Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Active, not recruiting
First Posted : October 10, 2012
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Salivary Gland Cancer Drug: Sorafenib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sorafenib in Recurrent and/or Metastatic Salivary Gland Carcinomas: Phase II Study
Study Start Date : September 2010
Primary Completion Date : October 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Sorafenib
    400 mg twice daily, on a continuous basis (each morning and evening), in 4 week cycles

Primary Outcome Measures :
  1. Objective response [ Time Frame: 8 weeks ]
    Response Rate according to RECIST criteria. Response will be evaluated every 2 months.

Secondary Outcome Measures :
  1. safety [ Time Frame: 4 weeks ]
    number of patients with adverse events

  2. response rate according to CHOI criteria [ Time Frame: 8 weeks ]
  3. correlation between CHOI criteria and outcome [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703455

IRCCS Istituto Nazionale Tumori
Milano, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Responsible Party: Lisa Licitra, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01703455     History of Changes
Other Study ID Numbers: INT29/10
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
Salivary gland cancer metastatic disease recurrent disease clinical trial

Additional relevant MeSH terms:
Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action