CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 147 enrolled
Drug / intervention
sorafenib tosylatedrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically or cytologically confirmed sarcoma of specified subtypes: giant hemangioma, angiosarcoma, malignant peripheral nerve sheath tumor, leiomyosarcoma, high-grade undifferentiated pleomorphic sarcoma, synovial sarcoma, or carcinosarcoma
  • ✓Metastatic, locally advanced, or locally recurrent disease
  • ✓Measurable disease: ≥1 lesion ≥20 mm by conventional imaging OR ≥10 mm by spiral CT scan
  • ✓ECOG performance status 0–2
Key exclusion· 9
  • ✕Gastrointestinal stromal tumor (GIST)
  • ✕Known brain metastases
  • ✕Symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or uncontrolled hypertension
  • ✕Active or ongoing infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00245102
NCT00245102Phase 2Completed
CompareCT.gov

A Multicenter Phase II Study of Sorafenib (BAY43-9006) in Non-GIST Sarcomas

National Cancer Institute (NCI)·interventional·Posted Oct 27, 2005·Updated May 23, 2014

In Brief

A Phase 2 clinical trial evaluating sorafenib tosylate for Adult Angiosarcoma and 14 related conditions. Completed, enrolled 147 participants across 1 site.

Detailed Summary

This phase II trial is studying how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent sarcoma. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Leiomyosarcoma, Adult Malignant Fibrous Histiocytoma, Adult Neurofibrosarcoma, Adult Synovial Sarcoma, Ovarian Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Uterine Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Uterine Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma, Uterine Leiomyosarcoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 27, 2005
Enrollment StartSep 1, 2005
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.7 years ago

Interventions

sorafenib tosylatedrug

Given orally