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

NCT ID: NCT00406601

Last Updated: 2010-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Sarcoma, Soft Tissue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sorafenib (BAY-43-9006)

800 mg/die orally on a continuous basis

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Istituto Clinico Humanitas

Principal Investigators

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Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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Istituto Clinico Humanitas

Rozzano, Milan, Italy

Site Status

Countries

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Italy

References

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Antman KH. Adjuvant therapy of sarcomas of soft tissue. Semin Oncol. 1997 Oct;24(5):556-60.

Reference Type BACKGROUND
PMID: 9344322 (View on PubMed)

Santoro A, Tursz T, Mouridsen H, Verweij J, Steward W, Somers R, Buesa J, Casali P, Spooner D, Rankin E, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1995 Jul;13(7):1537-45. doi: 10.1200/JCO.1995.13.7.1537.

Reference Type BACKGROUND
PMID: 7602342 (View on PubMed)

Other Identifiers

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EUDRACT 2006-004437-15

Identifier Type: -

Identifier Source: secondary_id

ONC-2006-002

Identifier Type: -

Identifier Source: org_study_id

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