NCT02606461

Selinexor in Advanced Liposarcoma

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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).

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unblinded and if receiving: * placebo, may cross over to open-label selinexor (60mg twice-weekly) * selinexor, will be withdrawn from further treatment and followed for survival Study treatment will be given twice-weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle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

Conditions

• Dedifferentiated Liposarcoma

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor 60mg
DRUG	Placebo

Timeline

• Start date: 2016-01-04
• Primary completion: 2020-10-28
• Completion: 2021-10-26
• First posted: 2015-11-17
• Last updated: 2023-01-23
• Results posted: 2021-12-07

Locations

71 sites across 10 countries: United States, Belgium, Canada, France, Germany, Israel, Italy, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study