Vanderbilt Clinical Trials

Selinexor in Advanced Liposarcoma

Purpose

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo).

Condition

Dedifferentiated Liposarcoma

Eligibility

Eligible Ages: Over 12 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Patients ≥12 years of age 2. Body surface area (BSA) ≥ 1.2 m2 3. Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment 4. Must have measurable disease per RECIST v1.1 Response Criteria 5. Radiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy 6. Must have had at least 2 prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines) 7. If patient received any previous systemic therapy, the last dose must have been ≥ 21 days prior to randomization (or ≥ 5 half-lives of that drug, whichever is shorter) with all clinically significant therapy-related toxicities having resolved to ≤ Grade 1

Exclusion Criteria

Patients with pure well-differentiated liposarcoma (WDLS), myxoid/round cell or pleomorphic tumor histologic subtypes 2. Known active hepatitis B (HepB), hepatitis C (HepC) or human immunodeficiency virus (HIV) infection 3. Known central nervous system metastases

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Phase 2 Double-blinded: Selinexor	Participants received a fixed blinding dose of 60 milligrams (mg) selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until progressive disease (PD).	Drug: Selinexor Selinexor 60mg Other names: KPT-330
Experimental Phase 3 Double-blinded: Selinexor	Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD.	Drug: Selinexor Selinexor 60mg Other names: KPT-330
Placebo Comparator Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor	Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD in double-blinded treatment period. Participants in the placebo group who had PD during the Phase 2 double-blinded treatment, will be elected to cross over to open-label selinexor.	Drug: Placebo Other names: sugar pill
Placebo Comparator Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor	Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD or development of unacceptable toxicity. Participants in the placebo group who had PD during the Phase 3 double-blinded treatment, will be elected to cross over to open-label selinexor.	Drug: Placebo Other names: sugar pill

More Details

Status: Completed
Sponsor: Karyopharm Therapeutics Inc

Study Contact

Detailed Description

In the Phase 2 portion of the study, 57 patients were randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio. In the Phase 3 portion of the study, approximately 285 patients will be randomized to selinexor (60 mg) or placebo with a 2:1 allocation ratio. Patients who progress during the blinded portion of the study will be unblinded and if receiving: - placebo, may cross over to open-label selinexor (60mg twice-weekly) - selinexor, will be withdrawn from further treatment and followed for survival Study treatment will be given twice-weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability. Treatment will continue until one or more of the following occurs: - Disease progression, as defined by RECIST v1.1 Response Criteria - Clinical progression, as determined by the treating physician - Unacceptable adverse events (AEs) or failure to tolerate study treatment - Patient withdrawal - Patient discontinuation due to non-compliance

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.