Phase 3
N=342
Selinexor in Advanced Liposarcoma
Dedifferentiated Liposarcoma
Bottom Line
View on ClinicalTrials.gov: NCT02606461 ↗Enrolled (actual)
342
Serious AEs
32.5%
Results posted
Dec 2021
Primary outcome: Primary: Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — 2.83; 2.07 Months — p=0.0114
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Selinexor (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Karyopharm Therapeutics Inc
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
2.83; 2.07 | 0.0114 sig |
| PRIMARY Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 |
2.73 | — |
| PRIMARY Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1 |
3.02; 2.76 | 0.6051 |
| PRIMARY Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 |
1.38 | — |
| SECONDARY Phase 3 Double Blind: Overall Survival (OS) |
10.38; 12.71 | — |
| SECONDARY Phase 3 Open Label: Overall Survival (OS) |
10.18 | — |
| SECONDARY Phase 2 Double Blind: Overall Survival (OS) |
17.31; 16.07 | — |
| SECONDARY Phase 2 Open Label: Overall Survival (OS) |
8.90 | — |
| SECONDARY Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1 |
2.83; 2.10 | — |
| SECONDARY Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1 |
2.73 | — |
| SECONDARY Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1 |
3.02; 2.76 | — |
| SECONDARY Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1 |
1.38 | — |
| SECONDARY Phase 3 Double Blind: Overall Response Rate (ORR) |
2.7; 0 | — |
| SECONDARY Phase 3 Open Label: Overall Response Rate (ORR) |
3.2 | — |
| SECONDARY Phase 2 Double Blind: Overall Response Rate (ORR) |
0; 0 | — |
| SECONDARY Phase 2 Open Label: Overall Response Rate (ORR) |
0; 0 | — |
| SECONDARY Phase 3 Double Blind: Duration of Response (DOR) |
7.39 | — |
| SECONDARY Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment |
2.89; 1.87 | — |
| SECONDARY Phase 3 Double Blind: Time to Next Treatment (TTNT) |
5.42; 3.22 | — |
| SECONDARY Phase 2 Double Blind: Time to Next Treatment (TTNT) |
4.96; 2.92 | — |
| SECONDARY Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
187; 94; 73; 18 | — |
| SECONDARY Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs |
63; 25 | — |
| SECONDARY Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs |
27; 29; 4; 6 | — |
| SECONDARY Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs |
24; 13 | — |
| SECONDARY Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30) |
33.33; 20.00; 16.67; 8.33; 50.00; 0.00 | — |
| SECONDARY Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30) |
-16.67; -40.00; -33.33; 0.00; -50.00; -16.67 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Patients ≥12 years of age
- Body surface area (BSA) ≥ 1.2 m2
- Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment
- Must have measurable disease per RECIST v1.1 Response Criteria
- 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
- Must have had at least 2 prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines)
- 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
- Known active hepatitis B (HepB), hepatitis C (HepC) or human immunodeficiency virus (HIV) infection
- Known central nervous system metastases
Data sourced from ClinicalTrials.gov (NCT02606461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.