Back to resultsBAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas
Primary Purpose
Sarcoma, Soft Tissue
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Sorafenib (BAY-43-9006)
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma, Soft Tissue
Eligibility Criteria
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.
Sites / Locations
- Istituto Clinico Humanitas
Outcomes
Primary Outcome Measures
Progression free survival rate
Secondary Outcome Measures
Overall response rate, overall disease control rate, overall survival
Full Information
NCT ID
NCT00406601
First Posted
November 29, 2006
Last Updated
September 1, 2010
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT00406601
Brief Title
BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas
Official Title
Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Soft Tissue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sorafenib (BAY-43-9006)
Intervention Description
800 mg/die orally on a continuous basis
Primary Outcome Measure Information:
Title
Progression free survival rate
Time Frame
at 6 months after enrollment
Secondary Outcome Measure Information:
Title
Overall response rate, overall disease control rate, overall survival
Time Frame
Tumor assessment, follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
9344322
Citation
Antman KH. Adjuvant therapy of sarcomas of soft tissue. Semin Oncol. 1997 Oct;24(5):556-60.
Results Reference
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PubMed Identifier
7602342
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. doi: 10.1200/JCO.1995.13.7.1537.
Results Reference
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BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas
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