Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01986348
Status:
TERMINATED
Last Update Posted:
2023-01-26
First Post:
2013-10-17
Brief Title:
Study Evaluating the Efficacy and Safety of Selinexor KPT-330 in Participants With Recurrent Gliomas
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Karyopharm Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Study Evaluating the Efficacy and Safety of Selinexor KPT-330 in Patients With Recurrent Gliomas
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to Sponsor decision all except 1 patient were off-treatment and 2 patients were in survival follow-up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KING
Brief Summary:
This is an open-label multicenter Phase 2 study to evaluate the efficacy and safety of oral selinexor in participants with recurrent gliomas
Detailed Description:
This is an open-label multicenter Phase 2 study to evaluate the efficacy and safety of oral selinexor in participants with recurrent gliomas
Initially the study included 2 arms an exploratory Surgical Arm Arm A with sequential enrollment for participants who require surgery and a medical arm Arm B for participants who are not eligible for surgery
Enrollment in Arm B was stopped to explore alternative dosing in Protocol Versions 40 to potentially improve tolerability Four arms Arms C D E and F were added to the Medical Arm in Protocol Version 40 Arms E and F were eliminated in protocol version 60 and no participants were ever enrolled in these arms
Participants in the primary population enrolled under Protocol Version 40 will be randomized to Arm C and Arm D approximately 30 participants per arm to explore alternative dosing to potentially improve tolerability
After screening and registrationrandomization in the study participants enrolling in Arm A or randomized to Arm C will receive 60 mg selinexor orally twice weekly Participants randomized to Arm D will receive 80 mg selinexor orally weekly
Participants will be treated until progression of disease or the development of unacceptable toxicities All participants will then undergo the End of Treatment EOT visit
Initially the study included 2 arms an exploratory Surgical Arm Arm A with sequential enrollment for participants who require surgery and a medical arm Arm B for participants who are not eligible for surgery
Enrollment in Arm B was stopped to explore alternative dosing in Protocol Versions 40 to potentially improve tolerability Four arms Arms C D E and F were added to the Medical Arm in Protocol Version 40 Arms E and F were eliminated in protocol version 60 and no participants were ever enrolled in these arms
Participants in the primary population enrolled under Protocol Version 40 will be randomized to Arm C and Arm D approximately 30 participants per arm to explore alternative dosing to potentially improve tolerability
After screening and registrationrandomization in the study participants enrolling in Arm A or randomized to Arm C will receive 60 mg selinexor orally twice weekly Participants randomized to Arm D will receive 80 mg selinexor orally weekly
Participants will be treated until progression of disease or the development of unacceptable toxicities All participants will then undergo the End of Treatment EOT visit
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