Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02213133
Status:
TERMINATED
Last Update Posted:
2023-01-26
First Post:
2014-08-07
Brief Title:
Selinexor Treatment of Advanced RelapsedRefractory Squamous Cell Carcinomas
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Karyopharm Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Open-Label Study of the Safety and Efficacy of the Selective Inhibitor of Nuclear Export SINE Selinexor KPT-330 in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Lung or Esophagus
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to enrollment challenges and availability of other options for lung cancer patients The termination is not a consequence of any safety concern
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARRS
Brief Summary:
Open-label multi-center single-arm Phase 2 study of oral selinexor in patients with SCC of the head and neck HN-SCC Cohort 1 lung L-SCC Cohort 2 or esophagus E-SCC Cohort 3 who have relapsed or have metastasis following chemotherapy
Detailed Description:
This is a multicenter open-label single-arm Phase 2 study of the SINE selinexor given orally to patients diagnosed with advanced SCC of the head and neck lung or esophagus who have experienced relapse andor metastasis following multiple prior chemotherapy treatments 2 lines of therapy
Patients will receive fixed doses of selinexor tablets twice weekly in 28-day cycles Patients may continue from one cycle to the next without interruption as along as all criteria are met and no reason for discontinuation occurs
Patients will receive fixed doses of selinexor tablets twice weekly in 28-day cycles Patients may continue from one cycle to the next without interruption as along as all criteria are met and no reason for discontinuation occurs
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