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Completed

NCT Number: NCT00406601

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

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

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Key information

Conditions

Sarcoma, Soft Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sorafenib (BAY-43-9006)

Drug

800 mg/die orally on a continuous basis

Primary outcomes

  1. Progression free survival rate

    Time frame: at 6 months after enrollment

Secondary outcomes

  1. Overall response rate, overall disease control rate, overall survival

    Time frame: Tumor assessment, follow-up

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Dec 4, 2006
Registry last updated
Sep 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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