Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-28 @ 12:02 AM
Study NCT ID:
NCT02351505
Status:
TERMINATED
Last Update Posted:
2016-05-16
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Selinexor in Treating Patients With Relapsed Small Cell Lung Cancer
Sponsor:
Erin Bertino
Organization:
Study Overview
Official Title:
An Investigator-Sponsored Phase 2 Study of Single Agent Selinexor (KPT-330) in Patients With Relapsed Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low patient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well selinexor work in treating patients with small-cell lung cancer that has returned after a period of improvement. One specific way cancer cells continue to grow is by getting rid of certain proteins called "tumor suppressor proteins: that would normally cause cancer cells to die. Selinexor works by trapping "tumor suppressing proteins" within the cell and may cause the cancer cells to die or stop growing.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of single agent selinexor as measured by progression free survival (PFS) in patients with relapsed chemotherapy-sensitive small cell lung cancer.
SECONDARY OBJECTIVES:
I. To evaluate the objective tumor response rate and disease control rate as determined by radiographic response.
II. To evaluate the overall survival (OS) in patients with relapsed small cell lung cancer.
III. To evaluate safety and tolerability of single agent selinexor in these patient populations.
IV. Comparison between each patient's time to progression (TTP) on selinexor with the TTP of his/her previous therapy(ies).
V. To evaluate correlative endpoints including tumor biopsy and analysis of secreted factors, leukocyte ribonucleic acid (RNA) analysis.
TERTIARY OBJECTIVES:
I. Analysis of secreted factors (nerve growth factor \[NGF\], brain-derived neurotrophic factor \[BDNF\]).
II. Tumor biopsy (baseline and cycle 2).
OUTLINE:
Patients receive selinexor orally (PO) twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 3 months, every 3 months for 1 year, and then every 6 months thereafter.
I. To evaluate the efficacy of single agent selinexor as measured by progression free survival (PFS) in patients with relapsed chemotherapy-sensitive small cell lung cancer.
SECONDARY OBJECTIVES:
I. To evaluate the objective tumor response rate and disease control rate as determined by radiographic response.
II. To evaluate the overall survival (OS) in patients with relapsed small cell lung cancer.
III. To evaluate safety and tolerability of single agent selinexor in these patient populations.
IV. Comparison between each patient's time to progression (TTP) on selinexor with the TTP of his/her previous therapy(ies).
V. To evaluate correlative endpoints including tumor biopsy and analysis of secreted factors, leukocyte ribonucleic acid (RNA) analysis.
TERTIARY OBJECTIVES:
I. Analysis of secreted factors (nerve growth factor \[NGF\], brain-derived neurotrophic factor \[BDNF\]).
II. Tumor biopsy (baseline and cycle 2).
OUTLINE:
Patients receive selinexor orally (PO) twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 3 months, every 3 months for 1 year, and then every 6 months thereafter.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-02489 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |