Last updated: 09/26/2025 16:00:09
A Study of Niraparib (GSK3985771) Maintenance Treatment in participants with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
GSK study ID
213359
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Trial description: This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Progression Free Survival
Timeframe: Up to 34 months
Secondary outcomes:
Overall Survival
Timeframe: Up to 34 months
Time to First Subsequent Therapy (TFST)
Timeframe: Up to 34 months
Progression-Free Survival-2 (PFS2)
Timeframe: Up to 34 months
Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)
Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24
Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score
Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24
Change From Baseline in Functional Scales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24
Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30
Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30
Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24
Change From Baseline in Functional Scales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)
Timeframe: Baseline (Day 1, Pre-dose) and Up to 34 months
Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28
Timeframe: Baseline (Day 1, Pre-dose) and Up to 34 months
Interventions:
Enrollment:
733
Primary completion date:
2019-17-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
B J Monk, M P Barretina-Ginesta, B Pothuri, I Vergote, W Graybill, M R Mirza, C C McCormick, D Lorusso, R G Moore, G Freyer, R E O'Cearbhaill, F Heitz, D M O'Malley, A Redondo, M S Shahin, C Vulsteke, W H Bradley, C A Haslund, D M Chase, C Pisano, L L Holman, M J Rubio Pérez, P DiSilvestro, L Gaba, T J Herzog, I Bruchim, N Compton, L Shtessel, I A Malinowska, A González-Martín. Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Annals of oncology : official journal of the European Society for Medical Oncology. 2024-Sep-14; doi:10.1016/j.annonc.2024.08.2241 http://dx.doi.org/S0923-7534(24)03762-110.1016/j.annonc.2024.08.2241
PMID: 39284381
DOI: 10.1016/j.annonc.2024.08.2241
Medical condition
Ovarian Neoplasms
Product
Not applicable
Collaborators
Gynecologic Oncology Group, European Network of Gynaecological Oncological Trial Group (ENGOT), Myriad Genetics, Inc.
Study date(s)
July 2016 to January 2026
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Participants must have histologically diagnosed high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to Federation Internationale de Gynécologie et d’Obstétrique (FIGO) criteria.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Participants must have histologically diagnosed high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to Federation Internationale de Gynécologie et d’Obstétrique (FIGO) criteria.
- Participants with inoperable Stage III and IV disease; All Stage IV participants with operable disease; Participants with stage III or IV disease treated with neoadjuvant chemotherapy and interval debulking surgery; and Participants with stage III disease who have visible residual disease after primary debulking surgery.
- Participants who have received intraperitoneal chemotherapy; All participants must have had more than or equal to (>=)6 and less than or equal to (<=)9 cycles of platinum-based therapy; Participants must have had >=2 post-operative cycles of platinum-based therapy following interval debulking surgery; Participants must have physician assessed Complete response (CR) or Partial response (PR) after >=3 cycles of therapy; and Participants must have either Cancer antigen 125 (CA-125) in the normal range or CA-125 decrease by more than 90 percent(%) during their front-line therapy that is stable for at least 7 days (no increase more than (>)15% from nadir).
- Participants must be randomized within 12 weeks of the first day of the last cycle of chemotherapy.
- All participants must agree to undergo central tumor HRD testing.
- Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin [hCG]) within 7 days prior to receiving the first dose of study treatment. Exclusion criteria:
- Participant has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer.
- Participants with Stage III disease who have had complete cytoreduction (no visible residual disease) after primary debulking surgery.
- Participant has undergone more than two debulking surgeries for the study disease.
- 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 has a known hypersensitivity to the components of niraparib or its excipients.
- Participant has received prior treatment with a known PARP inhibitor or has participated in a study where any treatment arm included administration of a known PARP inhibitor.
- Participant is to receive bevacizumab as maintenance treatment.
- Participant has had investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
- Participant has had any known >=Grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted >4 weeks.
- Participant has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the participation for the full duration of the study treatment, including: a) Participant received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment. b) Participant received colony-stimulating factors (e.g., granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment.
- Participant has been diagnosed and/or treated for invasive cancer less than 5 years prior to study enrollment.
Trial location(s)
Location
GSK Investigational Site
Baltimore, MD, United States, 21215-5271
Status
Study Complete
Showing 1 - 6 of 198 Results
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Recruitment complete
Actual primary completion date
2019-17-05
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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