TriangleNCT02655016 · CITED IN SOURCE DOCUMENTS
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-03-10
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.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression Free Survival
Overall Survival
Time to First Subsequent Therapy (TFST)
Progression-Free Survival-2 (PFS2)
Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)
Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)
Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28
Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE
Area Under the Curve (AUC) From 0 to the Last Quantifiable Concentration (AUC[0-last])
Peak Plasma Concentration (Cmax)
Number of Participants With Positive HRD Test
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility 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: 1. Participant received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment. 2. 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.
- gender Based
- true
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Niraparib
- label
- Participants receiving Niraparib
- type
- EXPERIMENTAL
- intervention Names
- Drug: Placebo
- label
- Participants receiving Placebo
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Participants receiving Niraparib
- description
- Niraparib will be administered.
- name
- Niraparib
- type
- DRUG
- arm Group Labels
- Participants receiving Placebo
- description
- Placebo will be administered.
- name
- Placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 733
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.
- measure
- Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE
- time Frame
- Up to 34 months
- description
- Blood samples were planned to be collected for assessment of AUC(0-last).
- measure
- Area Under the Curve (AUC) From 0 to the Last Quantifiable Concentration (AUC[0-last])
- time Frame
- Up to 34 months
- description
- Blood samples were planned to be collected for assessment of Cmax.
- measure
- Peak Plasma Concentration (Cmax)
- time Frame
- Up to 34 months
- description
- Number of participants with positive HRD test was planned to be assessed.
- measure
- Number of Participants With Positive HRD Test
- time Frame
- Up to 34 months
- primary Outcomes
- description
- Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.
- measure
- Progression Free Survival
- time Frame
- Up to 34 months
- secondary Outcomes
- description
- Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis.
- measure
- Overall Survival
- time Frame
- Up to 34 months
- description
- Time to first subsequent therapy was defined as the time from the date of randomization to the date of the first subsequent anti-cancer therapy or death, whichever occurs first. Median and 95% CI are presented.
- measure
- Time to First Subsequent Therapy (TFST)
- time Frame
- Up to 34 months
- description
- PFS2 was defined as the time from the date of randomization to the date of progression on the next anti-cancer therapy following study treatment or death by any cause, whichever occurs first. Median and 95% CI are presented.
- measure
- Progression-Free Survival-2 (PFS2)
- time Frame
- Up to 34 months
- description
- FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants responded to their symptom experience over the past 7 days using a 5-point Likert scale scored from "not at all" (0) to "very much" (4). FOSI score was calculated as (sum of item scores)\*8 divided by (number of items answered). The FOSI score ranged from 0 (severely symptomatic) to 32 (asymptomatic). A higher score indicated a better quality of life (QoL). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
- measure
- Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)
- time Frame
- Baseline (Day 1, Pre-dose) and Up to Week 24
- description
- The EQ-5D-5L is a well-validated general preference-based, health-related QoL instrument. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
- measure
- Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score
- time Frame
- Baseline (Day 1, Pre-dose) and Up to Week 24
- description
- EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Five functional scales had total 15 items (physical-5, role-2, cognitive-4, emotional-2, and social-2). Each functional scales score was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus \[average score minus 1\] divided by 3\*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
- measure
- Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
- time Frame
- Baseline (Day 1, Pre-dose) and Up to Week 24
- description
- EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. A global health status/QoL scale had total 2 items. Each global health status/QoL scales score was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 6\*100). The global health status/QoL scales range in score from 0 to 100. Higher score represents a higher ("better") level of health status/QoL. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
- measure
- Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30
- time Frame
- Baseline (Day 1, Pre-dose) and Up to Week 24
- description
- EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Symptom scale had total 7 items (fatigue-3, pain-2, nausea/vomiting-2). Each symptoms scales and 6 single additional symptoms items score was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 3\*100). All of the symptoms scales and 6 single additional symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
- measure
- Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30
- time Frame
- Baseline (Day 1, Pre-dose) and Up to Week 24
- description
- EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/gastrointestinal \[GI\] symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus \[average score minus 1\] divided by 3\*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 3\*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
- measure
- Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)
- time Frame
- Baseline (Day 1, Pre-dose) and Up to 34 months
- description
- EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/GI symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Symptoms scales score was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 3\*100). All of the symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
- measure
- Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28
- time Frame
- Baseline (Day 1, Pre-dose) and Up to 34 months
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- Monk BJ, Barretina-Ginesta MP, Pothuri B, Vergote I, Graybill W, Mirza MR, McCormick CC, Lorusso D, Moore RG, Freyer G, O'Cearbhaill RE, Heitz F, O'Malley DM, Redondo A, Shahin MS, Vulsteke C, Bradley WH, Haslund CA, Chase DM, Pisano C, Holman LL, Perez MJR, DiSilvestro P, Gaba L, Herzog TJ, Bruchim I, Compton N, Shtessel L, Malinowska IA, Gonzalez-Martin A. 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. Ann Oncol. 2024 Nov;35(11):981-992. doi: 10.1016/j.annonc.2024.08.2241. Epub 2024 Sep 14.
- pmid
- 39284381
- type
- BACKGROUND
- citation
- Shahin MS, Lorusso D, Backes FJ, Barretina-Ginesta MP, O'Malley DM, Forget F, Pothuri B, Hietanen S, McCormick CC, Abadie-Lacourtoisie S, O'Cearbhaill RE, Heitz F, Moore RG, Amit A, Willmott LJ, Perez MR, Burger RA, Redondo A, Chase DM, Romero I, Moore KN, Vergote I, Cloven N, Haslund CA, Graybill WS, Bergamini A, Berton D, Braicu EI, Lim JT, Golembesky AK, Shtessel L, Monk BJ, Gonzalez-Martin A. Updated patient-reported outcomes and the effect of disease progression on health-related quality of life in the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer. Gynecol Oncol. 2026 Jul 1;211:79-88. doi: 10.1016/j.ygyno.2026.06.010. Online ahead of print.
- pmid
- 42385609
- type
- DERIVED
- citation
- Monk BJ, Romero I, Graybill W, Churruca C, O'Malley DM, Knudsen AO, Yap OWS, Baurain JF, Rose PG, Denys H, Ghamande S, Pisano C, Fabbro M, Braicu EI, Calvert PM, Amit A, Prendergast E, Taylor A, Kheibarshekan L, Zhang ZY, Zajic S, Jewell RC, Gupta D, Gonzalez-Martin A. Niraparib Population Pharmacokinetics and Exposure-Response Relationships in Patients With Newly Diagnosed Advanced Ovarian Cancer. Clin Ther. 2024 Aug;46(8):612-621. doi: 10.1016/j.clinthera.2024.06.001. Epub 2024 Jul 16.
- pmid
- 39019698
- type
- DERIVED
- citation
- Vulsteke C, Chambers SK, Perez MJR, Chan JK, Raaschou-Jensen N, Zhuo Y, Lorusso D, Herzog TJ, de la Motte Rouge T, Thomes Pepin JA, Braicu EI, Chen LM, Levy T, Barter JF, Pilar Barretina-Ginesta M, Joosens E, York W, Malinowska IA, Gonzalez-Martin A, Monk BJ. Tolerability of the niraparib individualized starting dose in the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line maintenance therapy. Eur J Cancer. 2024 Sep;208:114157. doi: 10.1016/j.ejca.2024.114157. Epub 2024 Jun 10.
- pmid
- 39013265
- type
- DERIVED
- citation
- Graybill WS, Pardo Burdalo B, O'Malley DM, Vergote I, Monk BJ, Auranen A, Copeland LJ, Sabbatini R, Herzog TJ, Follana P, Pothuri B, Braicu EI, McCormick C, Yubero A, Moore RG, Vuylsteke P, Raaschou-Jensen N, York W, Hartman J, Gonzalez-Martin A. Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study. Int J Gynecol Cancer. 2024 Jul 1;34(7):1041-1050. doi: 10.1136/ijgc-2024-005356.
- pmid
- 38950925
- type
- DERIVED
- citation
- Valabrega G, Pothuri B, Oaknin A, Graybill WS, Sanchez AB, McCormick C, Baurain JF, Tinker AV, Denys H, O'Cearbhaill RE, Hietanen S, Moore RG, Knudsen AO, de La Motte Rouge T, Heitz F, Levy T, York W, Gupta D, Monk BJ, Gonzalez-Martin A. Efficacy and safety of niraparib in patients aged 65 years and older with advanced ovarian cancer: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Gynecol Oncol. 2024 Aug;187:128-138. doi: 10.1016/j.ygyno.2024.03.009. Epub 2024 Jun 3.
- pmid
- 38833992
- type
- DERIVED
- citation
- Gonzalez-Martin A, Pothuri B, Vergote I, Graybill W, Lorusso D, McCormick CC, Freyer G, Backes F, Heitz F, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Malinowska IA, Shtessel L, Compton N, Mirza MR, Monk BJ. Progression-free survival and safety at 3.5 years of follow-up: results from the randomized phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer - a plain language summary. Future Oncol. 2024;20(22):1531-1544. doi: 10.2217/fon-2023-0782. Epub 2024 Mar 19.
- pmid
- 38501262
- type
- DERIVED
- citation
- Pothuri B, Han S, Chase DM, Heitz F, Burger RA, Gaba L, Van Le L, Guerra E, Bender D, Korach J, Cloven N, Churruca C, Follana P, DiSilvestro P, Baurain JF, Jardon K, Pisano C, Peen U, Maenpaa J, Gupta D, Bacque E, Li Y, Compton N, Antonova J, Monk BJ, Gonzalez-Martin A. Health-related quality of life in patients with newly diagnosed advanced ovarian cancer treated with niraparib vs placebo: Results from the phase 3 randomized PRIMA/ENGOT-OV26/GOG-3012 trial. Gynecol Oncol. 2024 May;184:168-177. doi: 10.1016/j.ygyno.2024.01.021. Epub 2024 Feb 6.
- pmid
- 38325276
- type
- DERIVED
- citation
- Gonzalez-Martin A, Pothuri B, Vergote I, Graybill W, Lorusso D, McCormick CC, Freyer G, Backes F, Heitz F, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Malinowska IA, Shtessel L, Compton N, Mirza MR, Monk BJ. Progression-free survival and safety at 3.5years of follow-up: results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer. Eur J Cancer. 2023 Aug;189:112908. doi: 10.1016/j.ejca.2023.04.024. Epub 2023 May 3.
- pmid
- 37263896
- type
- DERIVED
- citation
- Barretina-Ginesta MP, Monk BJ, Han S, Pothuri B, Auranen A, Chase DM, Lorusso D, Anderson C, Abadie-Lacourtoisie S, Cloven N, Braicu EI, Amit A, Redondo A, Shah R, Kebede N, Hawkes C, Gupta D, Woodward T, O'Malley DM, Gonzalez-Martin A. Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial. Ther Adv Med Oncol. 2022 Sep 22;14:17588359221126149. doi: 10.1177/17588359221126149. eCollection 2022.
- pmid
- 36172173
- type
- DERIVED
- citation
- O'Cearbhaill RE, Perez-Fidalgo JA, Monk BJ, Tusquets I, McCormick C, Fuentes J, Moore RG, Vulsteke C, Shahin MS, Forget F, Bradley WH, Hietanen S, O'Malley DM, Dorum A, Slomovitz BM, Baumann K, Selle F, Calvert PM, Artioli G, Levy T, Kumar A, Malinowska IA, Li Y, Gupta D, Gonzalez-Martin A. Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study. Gynecol Oncol. 2022 Jul;166(1):36-43. doi: 10.1016/j.ygyno.2022.04.012. Epub 2022 May 9.
- pmid
- 35550709
- type
- DERIVED
- citation
- Gonzalez-Martin A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Perez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.
- pmid
- 31562799
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- 14 CLINICAL STUDIES 14.1 First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer PRIMA (NCT02655016) was a double-blind, placebo-controlled trial in which patients (N = 733) in complete or partial response to first-line platinum-based chemotherapy were random
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- name">BRCA1</em> or <em class="gene-name">BRCA2</em> variants.</li></ul></div></li></ol></div></li><li>A double-blind phase III trial (<a href="/clinicaltrials/NCT02655016">PRIMA</a> [NCT02655016]) compared maintenance niraparib (300 mg tablets once daily and later amended to 200 mg in women <77 kg and/or baseline platelet cou
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- 198986
- exact text
- NCT02655016
- start
- 198975
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- class="gene-name">BRCA2</em> variants.</li></ul></div></li></ol></div></li><li>A double-blind phase III trial (<a href="/clinicaltrials/NCT02655016">PRIMA</a> [NCT02655016]) compared maintenance niraparib (300 mg tablets once daily and later amended to 200 mg in women <77 kg and/or baseline platelet count <150,000/µL)
- end
- 199010
- exact text
- NCT02655016
- start
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- ref="/clinicaltrials/NCT02354586">QUADRA</a> (NCT02354586), <a href="/clinicaltrials/NCT02657889">TOPACIO</a> (NCT02657889) (ongoing), <a href="/clinicaltrials/NCT02655016">PRIMA</a> (NCT02655016) (ongoing), others ongoing</td> <td>Nausea, fatigue, constipation, hypertension, myelosuppression (especially ↓
- end
- 280021
- exact text
- NCT02655016
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- 02354586">QUADRA</a> (NCT02354586), <a href="/clinicaltrials/NCT02657889">TOPACIO</a> (NCT02657889) (ongoing), <a href="/clinicaltrials/NCT02655016">PRIMA</a> (NCT02655016) (ongoing), others ongoing</td> <td>Nausea, fatigue, constipation, hypertension, myelosuppression (especially ↓ platelets); rare cases
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- 280045
- exact text
- NCT02655016
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- Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment (PDQ®)–Health Professional Version
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- Updated: May 14, 2025
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- 2025-05-14T12:00:00Z
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- May 14, 2025
Preserved source evidence · Not medical advice