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

Istituto Clinico Humanitas69 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoma, Soft Tissue

Interventions

Sorafenib (BAY-43-9006)DRUG

800 mg/die orally on a continuous basis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Outcomes

Primary Outcomes

Progression free survival rate

Time frame: at 6 months after enrollment

Secondary Outcomes

Overall response rate, overall disease control rate, overall survival

Time frame: Tumor assessment, follow-up

Data from ClinicalTrials.gov

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