At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
sorafenib tosylate +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Clinical and Correlative Study of BAY 43-9006 (Sorafenib) IND 69,896 in Sarcoma
In Brief
A Phase 2 clinical trial evaluating sorafenib tosylate, therapeutic conventional surgery, and 4 other interventions for Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor and 8 related conditions. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This phase II trial is studying how well sorafenib works in treating patients with soft tissue sarcoma. Sorafenib may stop the growth of soft tissue sarcoma by blocking blood flow to the tumor and blocking some of the enzymes needed for tumor cell growth
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Osteosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Osteosarcoma, Stage I Adult Soft Tissue Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2006
Enrollment StartJun 2006
Primary CompletionDec 2007
Study CompletionJul 2008
TodayJul 2026
First PostedMay 26, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2007
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.1 years ago
Interventions
sorafenib tosylatedrug
Given PO
therapeutic conventional surgeryprocedure
Undergo surgery
laboratory biomarker analysisother
Correlative studies
pharmacological studyother
Correlative studies
computed tomographyprocedure
Correlative studies
dynamic contrast-enhanced magnetic resonance imagingprocedure
Correlative studies