Ignite Creation Date:
2024-05-06 @ 7:48 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02606461
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2015-10-13
Brief Title:
Selinexor in Advanced Liposarcoma
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Karyopharm Therapeutics Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEAL
Brief 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 11 allocation ratio
In the Phase 3 portion of the study approximately 285 patients will be randomized to selinexor 60 mg or placebo with a 21 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selinexor will be withdrawn from further treatment and followed for survival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 v11 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
In the Phase 3 portion of the study approximately 285 patients will be randomized to selinexor 60 mg or placebo with a 21 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selinexor will be withdrawn from further treatment and followed for survival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 v11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-003594-14 | EUDRACT_NUMBER | None | None |