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

Korábbi kezelés

• 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.
• 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 a previously or currently diagnosed MDS/ AML or pneumonitis.
• Participants who have not recovered sufficiently from prior surgery or anticancer treatment.
• 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.
• Previous enrolment in the present study.

Más betegség

• 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).
• 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.
• Participants who have known history of hepatitis B or hepatitis C.

Egyéb

• 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.

• 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.