Trial · NCT02655016
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
NCT02655016, Phase 3, Active not recruiting, Tesaro, Inc.; results first posted 2020-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy. Trials, record NCT02655016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02655016
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
- NCT number
- NCT02655016
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 733 participants, actual
- Lead sponsor
- Tesaro, Inc.
- Conditions
- Ovarian Neoplasms
- Interventions
- Niraparib, Placebo
- First posted
- 2016-01-13
- Last updated
- 2026-03-10
- Results first posted
- 2020-06-11
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | Up to 34 months | 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. |
| Secondary | Overall Survival | Up to 34 months | 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. |
| Secondary | Time to First Subsequent Therapy (TFST) | Up to 34 months | 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. |
| Secondary | Progression-Free Survival-2 (PFS2) | Up to 34 months | 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. |
| Secondary | Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) | Baseline (Day 1, Pre-dose) and Up to Week 24 | 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). |
| Secondary | Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score | Baseline (Day 1, Pre-dose) and Up to Week 24 | 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). |
| Secondary | Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) | Baseline (Day 1, Pre-dose) and Up to Week 24 | 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). |
| Secondary | Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30 | Baseline (Day 1, Pre-dose) and Up to Week 24 | 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). |
| Secondary | Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 | Baseline (Day 1, Pre-dose) and Up to Week 24 | 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). |
| Secondary | 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) | Baseline (Day 1, Pre-dose) and Up to 34 months | 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). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | Up to 34 months | Intent-to-Treat (ITT) population comprised of all participants who were randomized into the study. | Months | MEDIAN |
| SECONDARY | Overall Survival | Up to 34 months | ITT Population | Months | MEDIAN |
| SECONDARY | Time to First Subsequent Therapy (TFST) | Up to 34 months | ITT Population | Months | MEDIAN |
| SECONDARY | Progression-Free Survival-2 (PFS2) | Up to 34 months | ITT Population | Months | MEDIAN |
| SECONDARY | Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) | Baseline (Day 1, Pre-dose) and Up to Week 24 | ITT Population. Only those participants with data available at the specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score | Baseline (Day 1, Pre-dose) and Up to Week 24 | ITT Population. Only those participants with data available at the specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) | Baseline (Day 1, Pre-dose) and Up to Week 24 | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30 | Baseline (Day 1, Pre-dose) and Up to Week 24 | ITT Population. Only those participants with data available at the specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 | Baseline (Day 1, Pre-dose) and Up to Week 24 | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | Baseline (Day 1, Pre-dose) and Up to 34 months | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | Placebo | 8.2 | 95% Confidence Interval 7.3 to 8.5 | Months | |
| Progression Free Survival | Niraparib | 13.8 | 95% Confidence Interval 11.5 to 14.9 | Months | |
| Overall Survival | Placebo | NA | 95% Confidence Interval 25.0 to NA | Months | |
| Overall Survival | Niraparib | 30.3 | 95% Confidence Interval 30.3 to NA | Months | |
| Time to First Subsequent Therapy (TFST) | Placebo | 12.0 | 95% Confidence Interval 10.3 to 13.9 | Months | |
| Time to First Subsequent Therapy (TFST) | Niraparib | 18.6 | 95% Confidence Interval 15.8 to 24.7 | Months | |
| Progression-Free Survival-2 (PFS2) | Placebo | NA | 95% Confidence Interval NA to NA | Months | |
| Progression-Free Survival-2 (PFS2) | Niraparib | 27.2 | 95% Confidence Interval 25.3 to NA | Months | |
| Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) | Placebo | -0.3 | Standard Error 0.22 | Scores on a scale | |
| Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) | Niraparib | -0.4 | Standard Error 0.15 | Scores on a scale |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 246 | |
| Overall Study | STARTED | Niraparib | 487 | |
| Overall Study | Received Study Treatment | Placebo | 244 | |
| Overall Study | Received Study Treatment | Niraparib | 484 | |
| Overall Study | Ongoing With Treatment in the Study | Placebo | 69 | |
| Overall Study | Ongoing With Treatment in the Study | Niraparib | 177 | |
| Overall Study | COMPLETED | Placebo | 191 | |
| Overall Study | COMPLETED | Niraparib | 397 | |
| Overall Study | NOT COMPLETED | Placebo | 55 | |
| Overall Study | NOT COMPLETED | Niraparib | 90 |
Source ClinicalTrials.gov
Adverse events1,636
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 43 | 244 | 83 |
| other | Anaemia | Blood and lymphatic system disorders | Niraparib | 306 | 484 | 921 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Placebo | 0 | 244 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Niraparib | 1 | 484 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo | 0 | 244 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Niraparib | 1 | 484 | 1 |
| other | Haemorrhagic disorder | Blood and lymphatic system disorders | Placebo | 0 | 244 | 0 |
| other | Haemorrhagic disorder | Blood and lymphatic system disorders | Niraparib | 2 | 484 | 2 |
| other | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | Placebo | 0 | 244 | 0 |
| other | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | Niraparib | 1 | 484 | 1 |
1 to 10 of 1,636Source ClinicalTrials.gov
See all 1,636 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 31 | 244 |
| Total, all-cause mortality | Niraparib | 48 | 484 |
| Total, other adverse events | Placebo | 223 | 244 |
| Total, other adverse events | Niraparib | 478 | 484 |
| Total, serious adverse events | Placebo | 32 | 244 |
| Total, serious adverse events | Niraparib | 156 | 484 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Niraparib vs Placebo: deaths from any cause | Trial comparisons |
| Niraparib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02655016
GET https://conductscience.org/api/trials/v1/NCT02655016/results?page=2