Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655183
Status:
WITHDRAWN
Last Update Posted:
2021-06-30
First Post:
2020-11-27
Brief Title:
Study of M4344 in Combination With Niraparib
Sponsor:
EMD Serono Research Development Institute Inc
Organization:
EMD Serono
Study Overview
Official Title:
A Phase I Dose Escalation Study of ATR Inhibitor M4344 in Combination With Niraparib in Participants With Advanced Solid Tumors Followed by Phase II Cohort Expansion in Participants With Breast Cancer With DNA Damage Response DDR Mutations
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial withdrawn based on portfolio prioritization oral ATRi M1774 in combination with niraparib is under investigation in DDRiver Solid Tumor 301
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study will include 3 parts Aim of Part 1 of this study is to establish the maximum tolerated dose MTD and recommended dose for expansion RDE for M4344 is an Ataxia Telangiectasia Mutated and Rad3-related ATR inhibitors in combination with niraparib in participants with advanced solid tumors Aim of Parts 2 and 3 of the study is to provide clinical proof-of-concept for the preclinically predicted synergistic efficacy of ATR and polyADP-Ribose polymerase PARP inhibitors PARPi in defined populations of participants with advanced breast cancer aBC with DDR mutations with an unmet medical need
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?:
None
Is an FDA AA801 Violation?:
None