Trial Information
Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival rate
Outcome Time Frame:
at 6 months after enrollment
Safety Issue:
Yes
Principal Investigator
Armando Santoro, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Istituto Clinico Humanitas
Authority:
Italy: Ministry of Health
Study ID:
ONC-2006-002
NCT ID:
NCT00406601
Start Date:
November 2006
Completion Date:
September 2010
Related Keywords:
- Sarcoma, Soft Tissue
- Sarcoma