Ignite Creation Date:
2024-05-06 @ 12:46 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03840967
Status:
TERMINATED
Last Update Posted:
2024-06-04
First Post:
2019-02-12
Brief Title:
A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic EsophagealGastroesophageal JunctionProximal Gastric Adenocarcinoma
Sponsor:
Shadia Jalal MD
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase II Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Homologous Recombination HR Defective or Loss of Heterozygosity LOH High Metastatic EsophagealGastroesophageal JunctionProximal Gastric Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow accruals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients can be prescreened for the study at the time of diagnosis of locally advanced or metastatic disease by determining presence of LOH high status andor deleterious alterations in HR pathway genes in the most recent available tumor tissue sample or in blood if they are found to have germline mutations Patients with either somatic or germline mutations will be allowed At the time of disease progression patients with high LOH or deleterious alterations in HR pathway genes and satisfying all other inclusion criteria will be enrolled on the study Patients will be treated with niraparib flat dose orally every day for 28 days until disease progression unacceptable side effects withdrawal of consent or death CT of the chestabdomenpelvis will be performed every 2 months and response will be assessed by RECIST 11
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None