Last updated: 03/19/2025 13:20:19

A trial to evaluate the safety of Niraparib tablets in adult female participants with advanced or relapsed epithelial ovarian cancer

GSK study ID
220168
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Prospective, Multicentre, open labelled, single arm Phase-IV Clinical Trial of Niraparib in Indian Patients with advanced or relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy
Trial description: The goal of this clinical trial is to learn about the safety profile of niraparib in adult female participants for the treatment of advanced or relapsed epithelial ovarian cancer.
Primary purpose:
Treatment
Trial design:
Single Group
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with treatment-emergent adverse events (TEAEs)

Timeframe: Up to Day 105

Secondary outcomes:

Number of participants with serious adverse events (SAEs), TEAEs leading to death, TEAEs leading to dose reduction, TEAEs leading to treatment discontinuation

Timeframe: Up to Day 105

Interventions:
  • Drug: Niraparib
    • Enrollment:
    67
    Primary completion date:
    2026-20-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Ovarian Neoplasms
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    April 2025 to July 2026
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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.
    • 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).
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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