Ovarian NeoplasmsPhase 4NCT06887933
A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer
A Phase 4 study testing Niraparib in people with Ovarian Neoplasms, run by GlaxoSmithKline.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Niraparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2025to 8 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Ovarian Neoplasms
- Being tested
- Niraparib
- Keywords
- Niraparib, Ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Niraparib will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Niraparib | Experimental | Not described Receives: Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to Day 105
Secondary outcomes (1)
Number of participants with serious adverse events (SAEs), TEAEs leading to death, TEAEs leading to dose reduction, TEAEs leading to treatment discontinuation
Measured: Up to Day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start22 Apr 2025 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion8 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887933
- Sponsor's protocol ID
- 220168
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06887933
- Acronym / sponsor ID
- 220168
- Conditions
- Ovarian Neoplasms
- Keywords
- Niraparib, Ovarian cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 8 Jul 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib | Experimental | Drug: Niraparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiraparibNiraparib will be administered. | Drug | Niraparib |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to Day 105
1 secondary outcome
Number of participants with serious adverse events (SAEs), TEAEs leading to death, TEAEs leading to dose reduction, TEAEs leading to treatment discontinuation
Time frame: Up to Day 105
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Niraparib in people with Ovarian Neoplasms, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to Day 105). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.