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

Phase 2

Completed

• Conditions: Sarcoma, Soft Tissue

• Registration Number: NCT00406601
• Lead Sponsor: Istituto Clinico Humanitas

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.

(\*) as per Protocol Amendment No. 1 of 16 April 2007 approved by local IEC on 24 July 2007

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-12-04
• Primary Completion: 2010-06
• Status Verified: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-01
• Last Update Posted: 2010-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression free survival rate	at 6 months after enrollment

Secondary Outcome Measures

Name	Time	Method
Overall response rate, overall disease control rate, overall survival	Tumor assessment, follow-up

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy