BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas
Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy
2 other identifiers
interventional
69
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 29, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedSeptember 2, 2010
September 1, 2010
3.6 years
November 29, 2006
September 1, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival rate
at 6 months after enrollment
Secondary Outcomes (1)
Overall response rate, overall disease control rate, overall survival
Tumor assessment, follow-up
Interventions
800 mg/die orally on a continuous basis
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- metastatic brain disease; pregnant or breast-feeding patients; serious infections.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Clinico Humanitas
Rozzano, Milan, 20089, Italy
Related Publications (2)
Antman KH. Adjuvant therapy of sarcomas of soft tissue. Semin Oncol. 1997 Oct;24(5):556-60.
PMID: 9344322BACKGROUNDSantoro 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.
PMID: 7602342BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Armando Santoro, MD
Istituto Clinico Humanitas
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 29, 2006
First Posted
December 4, 2006
Study Start
November 1, 2006
Primary Completion
June 1, 2010
Study Completion
September 1, 2010
Last Updated
September 2, 2010
Record last verified: 2010-09