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WITHDRAWN
NCT04149145
PHASE1

Trial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian Cancer

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out if a new drug, M4344, is safe and has beneficial effects when given in combination with the PARP inhibitor, Niraparib, in women with recurrent ovarian cancer that has progressed while on a PARP inhibitor.

Official title: Trial of M4344 and Niraparib in Patients With PARP Resistant Recurrent Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2023-05

Completion Date

2027-05

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

DRUG

M4344+Niraparib

The first phase will be a 3+3 design of fixed dose Niraparib by mouth (PO) every day (QD) and M4344 will be escalated from 100-200 mg PO QD (28-day cycle). There will be a 4-week lead in with niraparib only.

DRUG

M4344+Niraparib

In the second phase eligible patients will receive combination Niraparib + the determined dose of M4344 from the first phase.