Trial · NCT02354586
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
NCT02354586, Phase 2, Completed, Tesaro, Inc.; results first posted 2020-04-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens. Trials, record NCT02354586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02354586
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
- NCT number
- NCT02354586
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 463 participants, actual
- Lead sponsor
- Tesaro, Inc.
- Conditions
- Ovarian Neoplasms, Ovarian Cancer
- Interventions
- Niraparib
- First posted
- 2015-02-03
- Last updated
- 2022-09-15
- Results first posted
- 2020-04-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 3 years | The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis, PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Primary Analysis Population comprised of participants who received 3 or 4 prior lines of therapy (LOT), had homologous recombination deficiency positive (HRDpos) tumors, had platinum-sensitive disease, and were poly(adenosine 5'-diphosphate \[ADP\]-ribose) polymerase inhibitors (PARPi) naïve. |
| Secondary | Duration of Response (DoR) | Up to 3 years | DoR was defined as the time from first documentation of CR or PR until the time of first documentation of disease progression (PD) as assessed by the Investigator per RECIST (version1.1). DoR was analyzed using Kaplan-Meier (KM) method. |
| Secondary | ORR by HRD Status and Breast Cancer Gene (BRCA) Status | Up to 3 years | The ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. ORR was evaluated for participants with following characteristics: HRD status (positive, negative and unknown) and BRCA status (mutation positive, wild-type and unknown). |
| Secondary | Disease Control Rate (DCR) | Up to 3 years | Disease control rate was defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (version1.1). The exact (Clopper-Pearson) method was used to calculate 95% confidence interval. |
| Secondary | Progression Free Survival | Up to 3 years | Progression-free survival was defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression as assessed by the Investigator per RECIST (version 1.1) or clinical criteria. Progression is defined using RECIST version1.1 as at least a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions. |
| Secondary | Overall Survival | Up to 3 years | Overall Survival was defined as the time from the date of the first dose to the date of death by any cause. It was calculated as (Date of Death minus First dose date plus 1) divided by 30.4375. |
| Secondary | Time to First Subsequent Therapy (TFST) | Up to 3 years | Time to first subsequent therapy (TFST) was defined as the time from the date of first dose to the date of first subsequent therapy or death, whichever occurs first. It was calculated as (Earlier of \[First dose of first subsequent therapy or death\] minus First dose date plus 1) divided by 30.4375. |
| Other | Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Any Serious Adverse Event (SAE) | Up to a maximum of 71.56 months | 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. Adverse events which were not serious were considered as Non-serious adverse events. |
| Other | Number of Participants With Abnormality in Hematology Parameters | Up to 3 years | Number of participants with abnormality in hematology parameters were planned to be analyzed. |
| Other | Number of Participants With Abnormality in Clinical Chemistry Parameters | Up to 3 years | Number of participants with abnormality in clinical chemistry parameters were planned to be analyzed. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Up to 3 years | Primary Analysis Population. Only those participants with data available at the specified time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | Up to 3 years | Intent-to-Treat (ITT) Population was comprised of all dosed participants with measurable disease at Baseline. Measurable disease at Baseline was determined by the existence of at least 1 target lesion at Baseline tumor scan based on investigator's assessment. Only those participants with data available at the specified time points were analyzed. | Months | MEDIAN |
| SECONDARY | ORR by HRD Status and Breast Cancer Gene (BRCA) Status | Up to 3 years | ITT Population. All the participants from the ITT Population were analyzed (461 participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Up to 3 years | ITT Population. Only those participants with data available at the specified time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival | Up to 3 years | ITT Population. Only those participants with data available at the specified time points were analyzed. | Months | MEDIAN |
| SECONDARY | Overall Survival | Up to 3 years | ITT Population. Only those participants with data available at the specified time points were analyzed. | Months | MEDIAN |
| SECONDARY | Time to First Subsequent Therapy (TFST) | Up to 3 years | ITT Population. Only those participants with data available at the specified time points were analyzed. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Any Serious Adverse Event (SAE) | Up to a maximum of 71.56 months | Safety Population was comprised of all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Abnormality in Hematology Parameters | Up to 3 years | Safety Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported. | ||
| OTHER_PRE_SPECIFIED | Number of Participants With Abnormality in Clinical Chemistry Parameters | Up to 3 years | Safety Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Niraparib 300 mg | 27.66 | 95% Confidence Interval 15.6 to 42.6 | Percentage of participants | |
| Duration of Response (DoR) | Niraparib 300 mg | 9.4 | 95% Confidence Interval 6.6 to 18.3 | Months | |
| ORR by HRD Status and Breast Cancer Gene (BRCA) Status | Niraparib 300 mg | HRD positive, n=221 | 14.0 | 95% Confidence Interval 9.7 to 19.3 | Percentage of participants |
| ORR by HRD Status and Breast Cancer Gene (BRCA) Status | Niraparib 300 mg | HRD negative, n=195 | 2.6 | 95% Confidence Interval 0.8 to 5.9 | Percentage of participants |
| ORR by HRD Status and Breast Cancer Gene (BRCA) Status | Niraparib 300 mg | HRD unknown, n=45 | 6.7 | 95% Confidence Interval 1.4 to 18.3 | Percentage of participants |
| ORR by HRD Status and Breast Cancer Gene (BRCA) Status | Niraparib 300 mg | BRCA mutation positive, n=87 | 23.0 | 95% Confidence Interval 14.6 to 33.2 | Percentage of participants |
| ORR by HRD Status and Breast Cancer Gene (BRCA) Status | Niraparib 300 mg | BRCA wild-type, n=317 | 5.0 | 95% Confidence Interval 2.9 to 8.1 | Percentage of participants |
| ORR by HRD Status and Breast Cancer Gene (BRCA) Status | Niraparib 300 mg | BRCA unknown, n=57 | 5.3 | 95% Confidence Interval 1.1 to 14.6 | Percentage of participants |
| Disease Control Rate (DCR) | Niraparib 300 mg | 49.02 | 95% Confidence Interval 44.4 to 53.7 | Percentage of participants | |
| Progression Free Survival | Niraparib 300 mg | 3.5 | 95% Confidence Interval 3.2 to 3.7 | Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Niraparib 300 mg | 463 | |
| Overall Study | COMPLETED | Niraparib 300 mg | 0 | |
| Overall Study | NOT COMPLETED | Niraparib 300 mg | 463 |
Source ClinicalTrials.gov
Adverse events652
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 | Niraparib 300 mg | 233 | 463 | |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Niraparib 300 mg | 1 | 463 | |
| other | Aplastic anaemia | Blood and lymphatic system disorders | Niraparib 300 mg | 1 | 463 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Niraparib 300 mg | 3 | 463 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Niraparib 300 mg | 2 | 463 | |
| other | Leukopenia | Blood and lymphatic system disorders | Niraparib 300 mg | 31 | 463 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Niraparib 300 mg | 4 | 463 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Niraparib 300 mg | 3 | 463 | |
| other | Lymphocytosis | Blood and lymphatic system disorders | Niraparib 300 mg | 1 | 463 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Niraparib 300 mg | 15 | 463 |
1 to 10 of 652Source ClinicalTrials.gov
See all 652 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Niraparib 300 mg | 232 | 463 |
| Total, other adverse events | Niraparib 300 mg | 461 | 463 |
| Total, serious adverse events | Niraparib 300 mg | 200 | 463 |
Source ClinicalTrials.gov
Papers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02354586
GET https://conductscience.org/api/trials/v1/NCT02354586/events?page=2