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Sorafenib in Recurrent and/or Metastatic Salivary Gland Carcinomas: Phase II Study


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Salivary Gland Cancer

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Trial Information

Sorafenib in Recurrent and/or Metastatic Salivary Gland Carcinomas: Phase II Study


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Objective response

Outcome Description:

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

Outcome Time Frame:

8 weeks

Safety Issue:

No

Authority:

Comitato Etico Indipendente:Fondazione IRCCS Istituto Nazionale Tumori

Study ID:

INT29/10

NCT ID:

NCT01703455

Start Date:

September 2010

Completion Date:

January 2013

Related Keywords:

  • Salivary Gland Cancer
  • Salivary gland cancer metastatic disease recurrent disease clinical trial
  • Salivary Gland Neoplasms

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