At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)
In Brief
A Phase 3 clinical trial evaluating Laboratory Biomarker Analysis, Placebo Administration, and 2 other interventions for Desmoid Fibromatosis. Completed, enrolled 87 participants across 150 sites in 2 countries.
Signals
Detailed Summary
This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. \[Funding Source - FDA OOPD\]
Study Details
Timeline
Arms & Interventions
Patients receive sorafenib tosylate PO QD on days 1-28.
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
Interventions
Optional correlative studies
Given PO
Optional ancillary studies
Given PO