A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer

Launched by GLAXOSMITHKLINE · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to understand how safe the medication niraparib is for adult women who have advanced or returning epithelial ovarian cancer. Niraparib is being studied for its effectiveness in helping women who have completed their initial chemotherapy and are in either complete or partial response to that treatment. The goal is to gather more information about how well this medicine works and to ensure that it can be used safely in these patients.

To be eligible for this study, participants must be women aged 18 and older who have been diagnosed with epithelial ovarian cancer confirmed by medical tests. They should also be in a good enough health condition, meaning their blood counts and other health factors meet specific criteria. Women who can have children need to be willing to use birth control during the study and for some time after. The study is not currently recruiting participants, but when it begins, those who join will undergo regular check-ups and monitoring to ensure their safety while taking niraparib.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female participants with ≥18 years of age, able to understand the study procedures and agree to participate in the study by providing written informed consent.
• • Histologically confirmed epithelial ovarian cancer.
• • Eligible for active study drug treatment according to the approved label - as monotherapy for the maintenance treatment of adult participants with advanced epithelial (International Federation of Gynecology and Obstetrics \[FIGO\] stage III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
• • as monotherapy for the maintenance treatment of adult participants with platinum-sensitive relapsed high grade serious epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
• • Laboratory complete blood count (CBC) criteria (Absolute neutrophil count ≥1,500/microliters \[μL\]; Platelets ≥100,000/μL; Hemoglobin ≥9 grams per decilitre \[g/dL\]).
• • Adequately controlled hypertension basis on investigator's discretion.
• • Women of childbearing potential must be ready to use contraceptive measures to avoid pregnancy during study period and until 180 days after the last dose.
• Exclusion Criteria:
• • Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for up to 180 days after the last dose of study treatment.
• • Participant had known, active hepatic disease, known case of end-stage renal disease (ESRD), known case of serious, uncontrolled medical disorder, any known history or current diagnosis of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
• • Any previous polymerases inhibitor (PARPi) treatment.
• • Participant with concomitant serious uncontrolled medical illness.
• • Participant is receiving niraparib for use that is not according to the approved label.
• • Participant with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
• • Participant with a previously or currently diagnosed MDS/ AML or pneumonitis.
• • Participants who have not recovered sufficiently from prior surgery or anticancer treatment.
• • Participants who have known history of hepatitis B or hepatitis C.
• • Participant with active infection such as tuberculosis (TB) Prior/concurrent clinical study experience.
• • Participation in another clinical study with a study drug administered in the last 3 months.
• • Judgment by the investigator that the participant should not take part in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
• • Previous enrolment in the present study.