Activity of Sorafenib in Salivary Gland Cancer

NCT01703455 | Completed Phase 2 DMC

• 1 other identifier: INT29/10
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Salivary Gland Cancer

Keywords

Salivary gland metastatic recurrent disease clinical trial

Outcome Measures

Primary Outcomes (1)

• Objective response

  Response Rate according to RECIST criteria. Response will be evaluated every 2 months.

  8 weeks

Secondary Outcomes (2)

• response rate according to CHOI criteria

  8 weeks

• correlation between CHOI criteria and outcome

  one year

Other Outcomes (1)

• adverse events

  4 weeks

Study Arms (1)

Sorafenib 400 mg twice daily

EXPERIMENTAL

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

Drug: Sorafenib

Interventions

Sorafenib DRUG

400 mg twice daily, on a continuous basis (each morning and evening), in 4 week cycles

Also known as: Nexavar

Sorafenib 400 mg twice daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lisa Licitra, MD, Prof

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: October 10, 2012
• Study Start: September 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

IT (1)