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M4344+Niraparib for Ovarian Cancer (PARP Trial)

Phase 1
Waitlist Available
Led By Rebecca C Arend, MD, MSPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, M4344, combined with Niraparib, in women whose ovarian cancer has come back and did not respond to previous treatments. The goal is to see if this combination is safe and effective. The treatment works by making it harder for cancer cells to repair themselves, potentially stopping the cancer from growing. Niraparib is an oral medication approved for maintenance treatment in ovarian cancer.

Eligible Conditions
  • Recurrent Ovarian Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD) of M4344 and Niraparib as defined by CTCAE 4.03
Percentage of patients with treatment emergent adverse events as defined by CTCAE v.4.03
Secondary study objectives
Overall Response Rate (ORR) as defined by RECIST v.1.1
Percentage progression free survival (PFS) as defined by RECIST v.1.1

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: M4344+NiraparibExperimental Treatment1 Intervention
all PARP resistant, recurrent ovarian cancer

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,635 Previous Clinical Trials
2,305,159 Total Patients Enrolled
16 Trials studying Ovarian Cancer
2,918 Patients Enrolled for Ovarian Cancer
Rebecca C Arend, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
1,500 Total Patients Enrolled
1 Trials studying Ovarian Cancer
1,500 Patients Enrolled for Ovarian Cancer
~0 spots leftby Oct 2025
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