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Activity of Sorafenib in Salivary Gland Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01703455
First received: April 6, 2012
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Salivary Gland Cancer
 Drug: Sorafenib
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • Objective response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Response Rate according to RECIST criteria. Response will be evaluated every 2 months.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 37
Study Start Date: September 2010
Estimated Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sorafenib
    400 mg twice daily, on a continuous basis (each morning and evening), in 4 week cycles
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703455

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

No publications provided

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
Study First Received: April 6, 2012
Last Updated: January 29, 2013
Health Authority: Comitato Etico Indipendente:Fondazione IRCCS Istituto Nazionale Tumori

Keywords provided by 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
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
 Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013