Ignite Creation Date:
2024-05-06 @ 2:47 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04421378
Status:
TERMINATED
Last Update Posted:
2023-09-06
First Post:
2020-06-01
Brief Title:
A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Karyopharm Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Study of Selinexor in Combination With Standard of Care SoC Therapy for Newly Diagnosed or Recurrent Glioblastoma
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Upon further consideration of the existing data and the competitive landscape Karyopharm Therapeutics Inc has decided not to pursue the ongoing development of Selinexor in GBM at this time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 12 study of selinexor in combination with standard of care SoC therapy for newly diagnosed glioblastoma nGBM or recurrent glioblastoma rGBM This study will be conducted in 2 phases a Phase 1a dose finding study followed by Phase 1b dose expansion and a Phase 2 randomized efficacy exploration study and will independently evaluate 3 different combination regimens in 3 treatment arms in patients with nGBM Arms A and B or with rGBM Arm C
Arm A evaluating the combination of selinexor with radiation therapy S-RT in nGBM participants with uMGMT
Arm B evaluating the combination of selinexor with radiation therapy and temozolomide TMZ S-TRT in nGBM participants with methylated-O6-methylguanine-DNA-methyltransferase mMGMT
Arm C evaluating the combination of selinexor with lomustine or carmustine if lomustine is not available S-LC in rGBM participants regardless of MGMT status
Arm D evaluating the combination of selinexor with bevacizumab in rGBM participants regardless of MGMT status
Arm E evaluating the combination of selinexor with tumor treating fields TTField in rGBM participants regardless of MGMT status
Arm A evaluating the combination of selinexor with radiation therapy S-RT in nGBM participants with uMGMT
Arm B evaluating the combination of selinexor with radiation therapy and temozolomide TMZ S-TRT in nGBM participants with methylated-O6-methylguanine-DNA-methyltransferase mMGMT
Arm C evaluating the combination of selinexor with lomustine or carmustine if lomustine is not available S-LC in rGBM participants regardless of MGMT status
Arm D evaluating the combination of selinexor with bevacizumab in rGBM participants regardless of MGMT status
Arm E evaluating the combination of selinexor with tumor treating fields TTField in rGBM participants regardless of MGMT status
Detailed Description:
None
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 |
|---|---|---|---|
| 2021-000080-67 | EUDRACT_NUMBER | None | None |