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BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas

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ClinicalTrials.gov Identifier: NCT00406601
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : September 2, 2010
Sponsor:
Information provided by:
Istituto Clinico Humanitas

Brief Summary:

The aim of this study (*) is to evaluate the progression free survival rate at 6 months, response rate, overall disease control rate, overall survival of BAY-43-9006 in soft tissue sarcoma patients.

(*) as per Protocol Amendment No. 1 of 16 April 2007 approved by local IEC on 24 July 2007


Condition or disease Intervention/treatment Phase
Sarcoma, Soft Tissue Drug: Sorafenib (BAY-43-9006) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy
Study Start Date : November 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Sorafenib (BAY-43-9006)
    800 mg/die orally on a continuous basis


Primary Outcome Measures :
  1. Progression free survival rate [ Time Frame: at 6 months after enrollment ]

Secondary Outcome Measures :
  1. Overall response rate, overall disease control rate, overall survival [ Time Frame: Tumor assessment, follow-up ]


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

Inclusion Criteria:

  • Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant and/or first line anthracycline-based regimen; age >=18 yrs; ECOG PS =2; at least 1 measurable target lesion; life expectancy >=12 wks; adequate medullary liver and renal function; written informed consent.

Exclusion Criteria:

  • metastatic brain disease; pregnant or breast-feeding patients; serious infections.

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): NCT00406601


Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas

Publications:
Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00406601     History of Changes
Other Study ID Numbers: ONC-2006-002
EUDRACT 2006-004437-15
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sorafenib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs