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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00406601
Other study ID # ONC-2006-002
Secondary ID EUDRACT 2006-004
Status Completed
Phase Phase 2
First received November 29, 2006
Last updated September 1, 2010
Start date November 2006
Est. completion date September 2010

Study information

Verified date September 2010
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date September 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Sorafenib (BAY-43-9006)
800 mg/die orally on a continuous basis

Locations

Country Name City State
Italy Istituto Clinico Humanitas Rozzano Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival rate at 6 months after enrollment Yes
Secondary Overall response rate, overall disease control rate, overall survival Tumor assessment, follow-up Yes
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