Niraparib for Ovarian Cancer

Overseen By Matthew Schlumbrecht, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Miami

Must not be taking: Cytotoxic, Hormonal

Disqualifiers: MDS, AML, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 22 months

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.

Research Team

Matthew Schlumbrecht, MD, MPH

Principal Investigator

University of Miami

Sophia HL George, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for women with ovarian cancer. It's looking at how genetic traits, like African ancestry, and environmental factors affect the outcomes of treatment with Niraparib—a drug that stops cancer cells from repairing their DNA.

Inclusion Criteria

My cancer is high-grade serous or endometrioid.

I am not allergic to niraparib or its ingredients.

I have finished treatment for advanced ovarian, fallopian tube, or peritoneal cancer.

Exclusion Criteria

My cancer is one of the specified types (e.g., low-grade serous, clear cell).

My high blood pressure is not under control.

I have a platelet disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Niraparib maintenance therapy for up to 24 cycles, 28 days per cycle

22 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Niraparib

Trial Overview Niraparib is being tested to see if it can help treat ovarian cancer by preventing cancer cells from fixing their genes, which may slow down or stop their growth and spread.

Participant Groups

Group I: Niraparib Maintenance Group Experimental Treatment 1 Intervention

Participants in this group will receive Niraparib maintenance therapy for up to 24 cycles, 28 days per cycle. Participants will be followed for up to one (1) year after completion of Niraparib therapy. Total participation is about three years.

Niraparib is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Zejula for:

• Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
• Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy

Approved in United States as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
• Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status

Approved in Canada as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School