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

Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00406601

Enrollment

Registered

2006-12-04

Start date

2006-11-30

Completion date

2010-09-30

Last updated

2010-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma, Soft Tissue

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

Interventions

DRUGSorafenib (BAY-43-9006)

800 mg/die orally on a continuous basis

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Progression free survival rate	at 6 months after enrollment

Secondary

Measure	Time frame
Overall response rate, overall disease control rate, overall survival	Tumor assessment, follow-up

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026