Ignite Creation Date:
2024-05-06 @ 9:00 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02873975
Status:
COMPLETED
Last Update Posted:
2022-10-21
First Post:
2016-08-17
Brief Title:
A Study of LY2606368 Prexasertib in Patients With Solid Tumors With Replicative Stress or Homologous Repair Deficiency
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of the CHK1 Inhibitor LY2606368 in Patients With Advanced Solid Tumors Exhibiting Replicative Stress or Homologous Recombination Repair Deficiency
Status:
COMPLETED
Status Verified Date:
2022-09
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:
This research study is studying a checkpoint kinase 1 CHK1 inhibitor as a possible treatment for advanced solid tumors that harbor genetic alterations in the homologous repair HR pathway genetic alterations that indicate replication stress or with CCNE1 amplification
Detailed Description:
This is an open label phase II two-arm study exploring the anti-tumor activity of the CHK1 inhibitor prexasertib LY2606368 in patients with advanced solid tumors exhibiting one of the following
1 Replicative stress including MYC amplification CCNE1 amplification Rb loss or an FBXW7 mutation
2 An HR deficiency including tumors with genomic or somatic mutations of BRCA1 BRCA2 PALB2 RAD51C RAD51D ATR ATM CHK2 or the Fanconi anemia pathway genes
3 A CCNE1 amplification
1 Replicative stress including MYC amplification CCNE1 amplification Rb loss or an FBXW7 mutation
2 An HR deficiency including tumors with genomic or somatic mutations of BRCA1 BRCA2 PALB2 RAD51C RAD51D ATR ATM CHK2 or the Fanconi anemia pathway genes
3 A CCNE1 amplification
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