This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Istituto Clinico Humanitas Identifier:
First received: November 29, 2006
Last updated: September 1, 2010
Last verified: September 2010

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 Intervention Phase
Sarcoma, Soft Tissue Drug: Sorafenib (BAY-43-9006) Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Istituto Clinico Humanitas:

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

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

Enrollment: 69
Study Start Date: November 2006
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sorafenib (BAY-43-9006)
    800 mg/die orally on a continuous basis

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00406601

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

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas Identifier: NCT00406601     History of Changes
Other Study ID Numbers: ONC-2006-002
EUDRACT 2006-004437-15
Study First Received: November 29, 2006
Last Updated: September 1, 2010

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on September 21, 2017