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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

PARP Trial Summary

This trial is testing a new drug, M4344, to see if it is safe and has benefits when given with another drug, Niraparib, to women with ovarian cancer that has come back while taking Niraparib.

Eligible Conditions
  • Recurrent Ovarian Cancer

PARP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Overall Response Rate (ORR) as defined by RECIST v.1.1
Percentage progression free survival (PFS) as defined by RECIST v.1.1

PARP 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
1,586 Previous Clinical Trials
2,280,232 Total Patients Enrolled
15 Trials studying Ovarian Cancer
1,438 Patients Enrolled for Ovarian Cancer
Rebecca C Arend, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are allowed to enroll in this trial?

"At this time, recruitment for this medical trial has ceased. It was initially published on December 1st 2022 and last modified on January 21 of the same year. However, if you're in search of other studies that might fit your needs, there are presently 1498 trials seeking patients with recurrent ovarian cancer and 99 investigations recruiting participants to assess M4344+Niraparib as a treatment option."

Answered by AI

Has research on the combination of M4344 and Niraparib been conducted previously?

"Currently, there are 99 scientific investigations in progress that focus on M4344+Niraparib. These trials span the globe with 2817 different sites participating; 13 of these studies have entered Phase 3. Although Washington, District of Columbia is home to many such clinical studies, other locations around the world take part as well."

Answered by AI

Is this undertaking a pioneering clinical trial?

"At present, there are 99 operational clinical trials involving M4344+Niraparib spanning 49 nations and 485 cities. The original trial for this drug combination was conducted in 2016 by Myriad Genetics, Inc.. This Phase 3 study included 733 patients and has since been supplemented with 17 additional medical studies."

Answered by AI

Is there an opportunity for enrollment in this clinical trial?

"According to clinicaltrials.gov, this research is not presently enrolling participants. The trial was first announced on December 1st 2022 and most recently revised on January 21st of the same year. Despite its current inactivity, there are still 1597 other studies actively seeking volunteers for their trials."

Answered by AI

Has the M4344+Niraparib combination been given authorization by the FDA?

"The safety of M4344+Niraparib is estimated at 1 due to its Phase 1 status, revealing a lack of clinical data confirming efficacy and safety."

Answered by AI
~0 spots leftby May 2024