Ignite Creation Date:
2024-05-06 @ 2:35 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02088541
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2014-03-09
Brief Title:
Selinexor KPT-330 in Older Patients With Relapsed AML
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Karyopharm Therapeutics Inc
Study Overview
Official Title:
A Randomized Open Label Phase 2 Study of the Selective Inhibitor of Nuclear Export SINE Selinexor KPT-330 Versus Specified Physicians Choice in Patients 60 Years Old With Relapsed or Refractory Acute Myeloid Leukemia AML Who Are Ineligible for Intensive Chemotherapy andor Transplantation
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:
SOPRA
Brief Summary:
This is a randomized multicenter open-label phase 2 study of the SINE compound selinexor given orally versus specified investigator choices one of three potential salvage therapies Participants age 60 years with relapsed or refractory AML of any type except for AML M3 after one prior therapy only who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy
Detailed Description:
This is a randomized multicenter open-label phase 2 study of the SINE compound selinexor given orally versus restricted investigator choice ie one of three potential salvage therapies
Participants who have never been transplant eligible are currently deemed unfit for intensive chemotherapy 60 years old who have AML except Acute Promyelocytic Leukemia APL AML M3 after one prior treatment of either hypomethylating agent or a regimen including Ara-C and are meeting the inclusion and exclusion criteria will be randomized to receive either oral selinexor or physicians choice one of three potential treatments best supportive care BSC alone or BSC hypomethylating agent or BSC low dose Ara-C until disease progression death or intolerance has occurred
Participants who have never been transplant eligible are currently deemed unfit for intensive chemotherapy 60 years old who have AML except Acute Promyelocytic Leukemia APL AML M3 after one prior treatment of either hypomethylating agent or a regimen including Ara-C and are meeting the inclusion and exclusion criteria will be randomized to receive either oral selinexor or physicians choice one of three potential treatments best supportive care BSC alone or BSC hypomethylating agent or BSC low dose Ara-C until disease progression death or intolerance has occurred
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