Status:

COMPLETED

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

Lead Sponsor:

Istituto Clinico Humanitas

Conditions:

Sarcoma, Soft Tissue

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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. ...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

November 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

69 Patients enrolled

Trial Details

Trial ID

NCT00406601

Start Date

November 1 2006

End Date

September 1 2010

Last Update

September 2 2010

Active Locations (1)

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1

Istituto Clinico Humanitas

Rozzano, Milan, Italy, 20089