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

I

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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