At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 56 enrolled
Drug / intervention
sorafenib tosylatedrug
Likely dose
sorafenib tosylate given orallyAI-extracted
Key inclusion· 8
- ✓Histologically or cytologically confirmed uterine carcinoma or carcinosarcoma that is advanced or recurrent and not amenable to curative surgery or radiotherapy
- ✓At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- ✓Tumor tissue block must be available
- ✓ECOG 0-2 OR Karnofsky 60-100%
Key exclusion· 8
- ✕No prior sorafenib
- ✕No prior antiangiogenesis therapy, MAPK-signaling agents, or VEGFR inhibitors
- ✕No more than 1 prior chemotherapy regimen
- ✕Known brain metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma
In Brief
A Phase 2 clinical trial evaluating sorafenib tosylate for Recurrent Uterine Sarcoma and 3 related conditions. Completed, enrolled 56 participants across 7 sites in 2 countries.
Detailed Summary
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Uterine Sarcoma, Stage III Uterine Sarcoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2005
First PostedOct 2005
Primary CompletionJul 2010
TodayJul 2026
First PostedOct 13, 2005
Enrollment StartFeb 1, 2005
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 20.7 years ago
Interventions
sorafenib tosylatedrug
Given orally