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Karyopharm - SEAL for De-differentiated Liposarcoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if study drug (selinexor) is safe and will work with patients who have de-differentiated liposarcoma compared to patients taking the placebo.

What is the Condition Being Studied?

Liposarcoma

Who Can Participate in the Study?

Adults with a diagnosis of de-differentiated liposarcoma that is unresectable (unsuitable for surgery)

Age Group
Adults

What is Involved?

If you choose to join this study, you will be involved in two parts: Screening and Treatment.

During Screening, you will:
- Have a physical exam
- Have blood draws, and a possible tumor tissue biopsy
- Complete quality of life surveys

During Treatment, you will:
- Be randomized (like flipping a coin) to get the study drug, selinexor, or a placebo (sugar pill)
- Complete tests, exams, and procedures that are standard of care and for study purposes
- Take the study drug or placebo for 6 week cycles until your disease gets worse or your physician asks you to stop

Study Details

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)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00072155
NCT:NCT02606461
Phase
Phase II/III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698