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

Istituto Clinico Humanitas

Status and phase: Completed; Phase 2

Conditions: Sarcoma, Soft Tissue

Treatments: Drug: Sorafenib (BAY-43-9006)

Study type: Interventional

Funder types: Other

Identifiers

NCT00406601

EUDRACT 2006-004437-15

ONC-2006-002

Details and patient eligibility

About

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

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)