A Phase II/III Study of Selinexor in Patients with Advanced Inoperable Dedifferentiated Liposarcoma

Full Title

A Phase 2-3, Multicenter, Randomized, Double-Blind Study of Selinexor (KPT-330) Versus Placebo in Patients with Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)

Purpose

Tumor suppressor proteins work inside normal cells to prevent the uncontrolled cell growth that can lead to cancer. Some cancer cells thrive by getting rid of tumor suppressor proteins. Selinexor (also known as KPT-330) is an investigational drug that works by trapping tumor suppressor proteins inside cancer cells, causing them to die or stop growing.

In this study, researchers are evaluating the safety and effectiveness of selinexor in patients with advanced inoperable dedifferentiated liposarcoma. Patients will be randomly assigned to receive selinexor or a placebo (inactive drug). Neither patients nor doctors will know if a patient is getting selinexor or placebo. Selinexor is taken orally (by mouth). Patients whose tumors continue to grow during the study and who are found to be assigned to the placebo group will have the option to switch over to selinexor.

Eligibility

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

  • Patients must have advanced inoperable dedifferentiated liposarcoma that has come back or continued to grow despite at least one prior regimen of therapy.
  • Patients' tumors must show significant evidence of growth during the previous 6 months, either during observation or active treatment, or must have come back within 6 months of surgery.
  • At least 4 weeks must pass between completion of prior therapies and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be able to swallow pills.
  • This study is for patients age 12 and older.

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

Protocol

16-382

Phase

II/III

Investigator

Co-Investigators

Locations