Selinexor in Advanced Liposarcoma

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 334 total patients will be randomized to study treatment (selinexor or placebo).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karyopharm Therapeutics Inc; Karyopharm Therapeutics, Inc

Criteria

Inclusion Criteria:

1. 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 two (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 less than or equal to Grade 1

Exclusion Criteria:

1. Patients with pure 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