Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01896505
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2013-06-11
Brief Title:
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Karyopharm Therapeutics Inc
Study Overview
Official Title:
An Open-Label Phase IB Trial To Evaluate the Effects of Food and Formulation on Pharmacokinetics of the Oral Selective Inhibitor of Nuclear ExportSINE Compound KPT-330 in Patients With Soft-Tissue or Bone Sarcoma
Status:
COMPLETED
Status Verified Date:
2023-03
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:
None
Brief Summary:
The purpose of this research study is to find out more information such as to determine the effects of high and low fat foods on the pharmacokinetics PK of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2 to evaluate tumor response in sarcoma participants in Arm 3 to compare the PK of 60 milligrams mg of the new 2nd generation tablet formulation and 60 mg of the selinexor suspension formula to the current 1st generation tablets
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None