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

Sarcoma, Soft Tissue Clinical Trial

Official title:

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

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

• Sarcoma
• Sarcoma, Soft Tissue

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