A PHASE 2-3, MULTICENTER, RANDOMIZED, DOUBLEBLIND STUDY OF SELINEXOR (KPT-330) VERSUS PLACEBO IN PATIENTS WITH ADVANCED UNRESECTABLE DEDIFFERENTIATED LIPOSARCOMA (DDLS)

Protocol: 
AAAQ6101
Phase: 
II/III

A PHASE 2-3, MULTICENTER, RANDOMIZED, DOUBLEBLIND STUDY OF SELINEXOR (KPT-330) VERSUS PLACEBO IN PATIENTS WITH ADVANCED UNRESECTABLE DEDIFFERENTIATED LIPOSARCOMA (DDLS)

This is a Phase 2-3 study evaluating the effects of selinexor in patients with advanced unresectable dedifferentiated liposarcoma (DDLS). This study drug selinexor works by trapping “tumor suppressing proteins” within the nucleus of the cells and thus causing the cancer cells to die or stop growing. Selinexor has previously been tested in humans to define a safe dose to be administered. It is not known at this time if selinexor will treat your cancer. Selinexor is currently being tested in other clinical trials in patients with advanced cancers. This study will examine the effects of selinexor on your cancer and on your body including any side-effects that you may experience.

Are you Eligible? (Inclusion Criteria)

1. Patients with a body surface area (BSA) >= 1.2 m2 as calculated per
Dubois 1916 or
Mosteller 1987
2. Histologic evidence of DDLS at any time prior to randomization AND
current
evidence of DDLS requiring treatment
3. Must have measurable disease by the bidimensional WHO Response Criteria
(Miller
1981)
4. Radiologic evidence of progressive disease during the 6 months prior to
randomization.
5. Must have had prior at least 1 line of systemic therapy for liposarcoma
(no maximum
number)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States