Selinexor in Advanced Liposarcoma

Conditions

• Dedifferentiated Liposarcoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
  Selinexor 60mg
• Placebo — DRUG

Study Details

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).

Key Dates

First listed

Nov 17, 2015

Start date

Jan 4, 2016

Status verified

Jan 2023

Primary completion

Oct 28, 2020

Completion

Oct 26, 2021

Study Design

Enrollment

342 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• 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).
• 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.
• 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.
• 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.

Primary Outcome Measure

Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) ]

Locations (26)

Find similar trials in Los Angeles, CA

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