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

Sponsor
University of Alabama at Birmingham
Study ID
NCT04149145
Phase
PHASE1
Status
Withdrawn

Conditions

  • Ovarian Cancer Recurrent

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2023
Status verified
Jun 2026
Primary completion
May 31, 2024
Completion
May 31, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: M4344+Niraparib
    all PARP resistant, recurrent ovarian cancer

Primary Outcome Measure

Percentage of patients with treatment emergent adverse events as defined by CTCAE v.4.03 [ Time Frame: Baseline through 1 year ]

Related Studies