Clinical Trial: Selinexor in Advanced Liposarcoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)
Brief Summary: This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 245 total patients will be randomized to study treatment (selinexor or placebo).
Detailed Summary:
In the Phase 2 portion of the study, approximately 50 patients will be randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio.
In the Phase 3 portion of the study, approximately 195 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- selinexor, will be withdrawn from further treatment and followed for survival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 WHO criteria
- Clinical progression, as determined by the treating physician
- Unacceptable AEs or failure to tolerate study treatment
- Patient withdrawal
- Patient discontinuation due to non-compliance
Sponsor: Karyopharm Therapeutics Inc
Current Primary Outcome: Assess and compare Progression-free Survival (PFS) of patients with advanced unresectable DDLS treated with selinexor (60 milligrams [mg]) or placebo. [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 30 months. ]
Original Primary Outcome:
- Assess and compare Progression-free Survival (PFS) of patients with advanced unresectable DDLS treated with selinexor (60 milligrams [mg]) or placebo. [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 30 months. ]
- Primary analysis of PFS -performed on the intent-to-treat (ITT) population. [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 12 months. ]Phase 2 PFS data will inform adjustment of the Phase 3 sample size
- Time to progression (TTP) [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 30 months. ]
- Quality of Life as measured by the EORTC QLQ-C30 total score. [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 30 months. ]For EORTC QLQ-C30, the transformed score will be used, calculated according to the EORTC QLQ-C30 Scoring Manual.
- Quality of Life as measured by the EQ-5D-5L category scores and total score. [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 30 months. ]For the EQ-5D-5L questionnaire, the overall health score will be used.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Karyopharm Therapeutics Inc
Dates:
Date Received: October 13, 2015
Date Started: December 2015
Date Completion: July 2019
Last Updated: April 6, 2017
Last Verified: April 2017