A Phase III Study of Sorafenib versus Placebo in Patients with Desmoid Tumors

Protocol
14-015
Full Title
A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF) (Alliance A091105)
Phase
III
Purpose

Desmoid tumors (also called aggressive fibromatoses) are sarcomas that affect fibrous tissues. They can be challenging to treat successfully. In this study, researchers are comparing the effectiveness of sorafenib with placebo in patients with desmoid tumors. Patients in the placebo group whose cancers continue to grow will be able to switch to sorafenib.

Sorafenib works by targeting several proteins involved in cancer growth. It is approved for treating cancers of the liver, kidney, and thyroid, but its use for treating desmoid tumors is considered investigational. It is taken orally (by mouth).

Patients will be randomly assigned to receive sorafenib (two-thirds of the patients) or a placebo (the remaining third).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a desmoid tumor that is causing symptoms, is growing, or cannot be removed with surgery.
  • Any prior treatment must have been completed at least 4 weeks before entering the study. Previous treatment with sorafenib is not permitted.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mrinal Gounder at 646-888-4226.

Disease(s)
Sarcomas: Soft Tissue Sarcoma
Locations
Related Diseases