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Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis

NCT02066181 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2023-06-07

Study results available
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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. \[Funding Source - FDA OOPD\]

Conditions

  • Desmoid Fibromatosis

Interventions

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

OTHER

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Optional ancillary studies

DRUG

Sorafenib Tosylate

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Mrinal M Gounder · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-21
Primary Completion
2019-07-03
Completion
2022-12-01

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02066181 on ClinicalTrials.gov