Ignite Creation Date:
2024-05-06 @ 9:32 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03009682
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2016-12-27
Brief Title:
Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 12 Mutations ATM Deficiency or MRE11A Mutations
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Phase II Single-arm Study of Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 12 Mutations ATM Deficiency or MRE11A MutationsSUKSES-B
Status:
COMPLETED
Status Verified Date:
2021-02
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:
SUKSES-B
Brief Summary:
This study is a single arm multi-center phase II study of olaparib monotherapy in patients with relapsed small cell lung cancer SCLC harboring HR pathway gene mutations not limited to BRCA 12 mutations ATM deficiency or MRE11A mutations as second or third line chemotherapy
Target subject population
Patients with small cell lung cancer that have progressed following first-line platinum-based therapy Patients must have imaging confirmed progression on 1st line chemotherapy for SCLC treatment which must have contained platinum-based regimen with at least one measurable lesion per RECIST 11
Target subject population
Patients with small cell lung cancer that have progressed following first-line platinum-based therapy Patients must have imaging confirmed progression on 1st line chemotherapy for SCLC treatment which must have contained platinum-based regimen with at least one measurable lesion per RECIST 11
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