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A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Primary Purpose

Ovarian Neoplasms, Platinum Sensitive Ovarian Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Active comparator: Niraparib

placebo

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring ovarian cancer, platinum sensitive, gBRCAmut, BRCA, high-grade serous histology, PARP inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18 years of age or older, female, any race
Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
High grade (or grade 3) serous histology or known to have gBRCAmut
Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
ECOG 0-1
Adequate bone marrow, kidney and liver function

Exclusion Criteria:

Known hypersensitivity to the components of niraparib
Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
Symptomatic uncontrolled brain metastasis
Is pregnant or breast feeding
Immunocompromised patients
Known active hepatic disease
Prior treatment with a known PARP inhibitor

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Niraparib

Placebo

Arm Description

2:1 Ratio administered once daily continuously during a 28 day cycle.

Administered once daily continuously over a 28 day cycle.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)

PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)

PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation

PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Secondary Outcome Measures

Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)

The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.

Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation

The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death

Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)

Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment

Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation

Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment

Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)

Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.

Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation

Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)

Overall survival was defined as the date of randomization to the date of death by any cause.

Overall Survival in Cohort With No Germline BRCA Mutation

Overall survival was defined as the date of randomization to the date of death by any cause.

Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)

TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.

Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation

TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2

Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression

Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2

EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4

Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6

Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression

Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2

Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4

Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6

Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline

A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit"). Baseline was latest non-missing pre-dose assessment on or before randomization date.

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression

Number of Participants With Concordance of a Candidate Companion BRAC Analysis Diagnostic Test Compared to the Centralized BRCA Mutation Test Used in This Study

This will never be analyzed since the data for the candidate companion BRAC analysis diagnostic test was not collected which was to be compared with centralized BRCA mutation test used in this study.

Number of Participants With Concordance of a Candidate Companion HRD Diagnostic Test Compared to the HRD Test Used in This Study

This will never be analyzed since the data for the candidate companion HRD diagnostic test was not collected which was to be compared with HRD test used in this study.

Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)

An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. Data presented for this outcome measure is based on the data cut-off date of 31-March-2021, which aligns with the time of the study unblinding.

Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)

An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. The data is presented for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

Number of Participants With Non-serious AEs and SAEs in FE Sub-study

Number of Participants With Non-serious AEs and SAEs in QTc Sub-study

Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)

Blood samples were collected at indicated time points to analyze AUC(0-infinity) of niraparib.

Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-last]) Following Administration of Niraparib (FE Sub-study)

Blood samples were collected at indicated time points to analyze the AUC(0-last) of niraparib.

Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)

Blood samples were collected at indicated time points to analyze the maximum observed plasma concentration of niraparib.

Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)

Blood samples were collected at indicated time points to analyze the tmax of niraparib.

Terminal Elimination Half-life (t1/2) Following Administration of Niraparib (FE Sub-study)

Blood samples were collected at indicated time points to analyze the t1/2 of niraparib.

Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds

12-lead electrocardiogram was obtained at indicated time points using an automated electrocardiogram machine that measured QTcF interval. The number of participants with maximum post-Baseline ECG value exceeding the following limits have been reported: QTcF interval >450 and <= 480 milliseconds (msec) and >500 msec.

Full Information

NCT ID

NCT01847274

First Posted

April 11, 2013

Last Updated

May 31, 2023

Sponsor

Tesaro, Inc.

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetics, Inc., US Oncology Research, Sarah Cannon, Cooperative Ovarian Cancer Group (COGI), Facing Our Risk of Cancer Empowered

1. Study Identification

Unique Protocol Identification Number

NCT01847274

Brief Title

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Official Title

A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

June 21, 2013 (Actual)

Primary Completion Date

April 22, 2016 (Actual)

Study Completion Date

December 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tesaro, Inc.

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Neoplasms, Platinum Sensitive Ovarian Cancer

Keywords

ovarian cancer, platinum sensitive, gBRCAmut, BRCA, high-grade serous histology, PARP inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

596 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Niraparib

Arm Type

Active Comparator

Arm Description

2:1 Ratio administered once daily continuously during a 28 day cycle.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Administered once daily continuously over a 28 day cycle.

Intervention Type

Drug

Intervention Name(s)

Active comparator: Niraparib

Other Intervention Name(s)

Niraparib

Intervention Description

Niraparib vs placebo 2:1 ratio

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)

Description

Time Frame

From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days

Title

Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)

Description

PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Time Frame

From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days

Title

Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation

Description

PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Time Frame

From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days

Secondary Outcome Measure Information:

Title

Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)

Description

The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.

Time Frame

From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days

Title

Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation

Description

The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death

Time Frame

From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days

Title

Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)

Description

Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment

Time Frame

From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days

Title

Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation

Description

Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment

Time Frame

From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days

Title

Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)

Description

Time Frame

From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days

Title

Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation

Description

Time Frame

From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days

Title

Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)

Description

Overall survival was defined as the date of randomization to the date of death by any cause.

Time Frame

From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days

Title

Overall Survival in Cohort With No Germline BRCA Mutation

Description

Overall survival was defined as the date of randomization to the date of death by any cause.

Time Frame

From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days

Title

Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)

Description

TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.

Time Frame

From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days

Title

Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation

Description

TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.

Time Frame

From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2

Description

Time Frame

Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6

Description

Time Frame

Baseline (pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression

Description

Time Frame

Baseline (Pre-dose on Cycle 1 Day 1, Each cycle was of 28 days) and up to 7 years, 7 months and 4 days

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression

Description

Time Frame

Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days

Title

Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)

Title

Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)

Title

Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)

Title

Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression

Description

Time Frame

Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days

Title

Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)

Title

Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)

Title

Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6

Description

Time Frame

Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)

Title

Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression

Description

Time Frame

Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline

Description

Time Frame

At Baseline

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2

Description

Time Frame

At Cycle 2 (Each cycle was of 28 days)

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4

Description

Time Frame

At Cycle 4 (Each cycle was of 28 days)

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6

Description

Time Frame

At Cycle 6 (Each cycle was of 28 days)

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression

Description

Time Frame

Up to 7 years, 7 months and 4 days

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline

Description

Time Frame

At Baseline

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2

Description

Time Frame

At Cycle 2 (Each cycle was of 28 days)

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4

Description

Time Frame

At Cycle 4 (Each cycle was of 28 days)

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6

Description

Time Frame

At Cycle 6 (Each cycle was of 28 days)

Title

Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression

Description

Time Frame

Up to 7 years, 7 months and 4 days

Title

Number of Participants With Concordance of a Candidate Companion BRAC Analysis Diagnostic Test Compared to the Centralized BRCA Mutation Test Used in This Study

Description

This will never be analyzed since the data for the candidate companion BRAC analysis diagnostic test was not collected which was to be compared with centralized BRCA mutation test used in this study.

Time Frame

Up to 7 years, 7 months and 4 days

Title

Number of Participants With Concordance of a Candidate Companion HRD Diagnostic Test Compared to the HRD Test Used in This Study

Description

This will never be analyzed since the data for the candidate companion HRD diagnostic test was not collected which was to be compared with HRD test used in this study.

Time Frame

Up to 7 years, 7 months and 4 days

Title

Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)

Description

Time Frame

Up to 7 years, 7 months and 6 days

Title

Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)

Description

An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. The data is presented for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

Time Frame

Up to 8 months, 26 days

Title

Number of Participants With Non-serious AEs and SAEs in FE Sub-study

Description

Time Frame

Up to 2 years, 3 months and 11 days

Title

Number of Participants With Non-serious AEs and SAEs in QTc Sub-study

Description

Time Frame

Up to 5 years 10 months and 22 days

Title

Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)

Description

Blood samples were collected at indicated time points to analyze AUC(0-infinity) of niraparib.

Time Frame

Pre-dose and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

Title

Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-last]) Following Administration of Niraparib (FE Sub-study)

Description

Blood samples were collected at indicated time points to analyze the AUC(0-last) of niraparib.

Time Frame

Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

Title

Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)

Description

Blood samples were collected at indicated time points to analyze the maximum observed plasma concentration of niraparib.

Time Frame

Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

Title

Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)

Description

Blood samples were collected at indicated time points to analyze the tmax of niraparib.

Time Frame

Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

Title

Terminal Elimination Half-life (t1/2) Following Administration of Niraparib (FE Sub-study)

Description

Blood samples were collected at indicated time points to analyze the t1/2 of niraparib.

Time Frame

Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

Title

Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds

Description

Time Frame

At Baseline (Cycle 1 Day 1, each cycle was of 28 days)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age or older, female, any race Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer High grade (or grade 3) serous histology or known to have gBRCAmut Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease) Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen ECOG 0-1 Adequate bone marrow, kidney and liver function Exclusion Criteria: Known hypersensitivity to the components of niraparib Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated) Symptomatic uncontrolled brain metastasis Is pregnant or breast feeding Immunocompromised patients Known active hepatic disease Prior treatment with a known PARP inhibitor

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Studies

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

GSK Investigational Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

GSK Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

GSK Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

GSK Investigational Site

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

GSK Investigational Site

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07962-1956

Country

United States

Facility Name

GSK Investigational Site

City

Farmington

State/Province

New Mexico

ZIP/Postal Code

87401

Country

United States

Facility Name

GSK Investigational Site

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

Oregon

ZIP/Postal Code

98684

Country

United States

Facility Name

GSK Investigational Site

City

Abington

State/Province

Pennsylvania

ZIP/Postal Code

19001-3788

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

GSK Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02905

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

GSK Investigational Site

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

GSK Investigational Site

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

Facility Name

GSK Investigational Site

City

Innsbruck

ZIP/Postal Code

A-6020

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

GSK Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

GSK Investigational Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

GSK Investigational Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 5L3

Country

Canada

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

GSK Investigational Site

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

GSK Investigational Site

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

Facility Name

GSK Investigational Site

City

Herlev

ZIP/Postal Code

DK-2730

Country

Denmark

Facility Name

GSK Investigational Site

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

GSK Investigational Site

City

Besançon Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

GSK Investigational Site

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

GSK Investigational Site

City

Montpellier Cedex 5

ZIP/Postal Code

34298

Country

France

Facility Name

GSK Investigational Site

City

Nice

ZIP/Postal Code

06189

Country

France

Facility Name

GSK Investigational Site

City

Saint Brieuc

ZIP/Postal Code

22015 cedex

Country

France

Facility Name

GSK Investigational Site

City

Saint-Herblain cedex

ZIP/Postal Code

44805

Country

France

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81377

Country

Germany

Facility Name

GSK Investigational Site

City

Goettingen

State/Province

Niedersachsen

ZIP/Postal Code

37075

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30177

Country

Germany

Facility Name

GSK Investigational Site

City

Duesseldorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

40217

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45122

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45136

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

GSK Investigational Site

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

GSK Investigational Site

City

Szolnok

ZIP/Postal Code

5004

Country

Hungary

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

GSK Investigational Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

GSK Investigational Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

GSK Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

GSK Investigational Site

City

Kfar-Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

GSK Investigational Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

GSK Investigational Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

GSK Investigational Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

GSK Investigational Site

City

Brescia

State/Province

Lombardia

ZIP/Postal Code

25123

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20141

Country

Italy

Facility Name

GSK Investigational Site

City

Catania

State/Province

Sicilia

ZIP/Postal Code

95126

Country

Italy

Facility Name

GSK Investigational Site

City

MIlano

ZIP/Postal Code

20133

Country

Italy

Facility Name

GSK Investigational Site

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

GSK Investigational Site

City

Oslo

ZIP/Postal Code

0379

Country

Norway

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-207

Country

Poland

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

94-029

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

GSK Investigational Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Name

GSK Investigational Site

City

Linköping

ZIP/Postal Code

SE-581 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

GSK Investigational Site

City

Nottingham

State/Province

Nottinghamshire

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Yeovil

State/Province

Somerset

ZIP/Postal Code

BA21 4AT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B18 7QH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bebington, Wirral

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SW36JJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Maidstone

ZIP/Postal Code

ME16 9QQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Rhyl

ZIP/Postal Code

LL18 5UJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Taunton

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27717299

Citation

Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Madry R, Christensen RD, Berek JS, Dorum A, Tinker AV, du Bois A, Gonzalez-Martin A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. doi: 10.1056/NEJMoa1611310. Epub 2016 Oct 7.

Results Reference

background

PubMed Identifier

36970052

Citation

Mirza MR, Lindahl G, Mahner S, Redondo A, Fabbro M, Rimel BJ, Herrstedt J, Oza AM, Canzler U, Berek JS, Gonzalez-Martin A, Follana P, Lord R, Azodi M, Estenson K, Wang Z, Li Y, Gupta D, Matulonis U, Feng B. Ad hoc Analysis of the Phase III ENGOT-OV16/NOVA Study: Niraparib Efficacy in Germline BRCA Wild-type Recurrent Ovarian Cancer with Homologous Recombination Repair Defects. Cancer Res Commun. 2022 Nov 15;2(11):1436-1444. doi: 10.1158/2767-9764.CRC-22-0240. eCollection 2022 Nov.

Results Reference

background

PubMed Identifier

35170751

Citation

Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.

Results Reference

derived

PubMed Identifier

32981695

Citation

Mirza MR, Benigno B, Dorum A, Mahner S, Bessette P, Barcelo IB, Berton-Rigaud D, Ledermann JA, Rimel BJ, Herrstedt J, Lau S, du Bois A, Herraez AC, Kalbacher E, Buscema J, Lorusso D, Vergote I, Levy T, Wang P, de Jong FA, Gupta D, Matulonis UA. Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial. Gynecol Oncol. 2020 Nov;159(2):442-448. doi: 10.1016/j.ygyno.2020.09.006. Epub 2020 Sep 25.

Results Reference

derived

PubMed Identifier

31518175

Citation

Matulonis UA, Walder L, Nottrup TJ, Bessette P, Mahner S, Gil-Martin M, Kalbacher E, Ledermann JA, Wenham RM, Woie K, Lau S, Marme F, Casado Herraez A, Hardy-Bessard AC, Banerjee S, Lindahl G, Benigno B, Buscema J, Travers K, Guy H, Mirza MR. Niraparib Maintenance Treatment Improves Time Without Symptoms or Toxicity (TWiST) Versus Routine Surveillance in Recurrent Ovarian Cancer: A TWiST Analysis of the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Dec 1;37(34):3183-3191. doi: 10.1200/JCO.19.00917. Epub 2019 Sep 16.

Results Reference

derived

PubMed Identifier

31173551

Citation

Del Campo JM, Matulonis UA, Malander S, Provencher D, Mahner S, Follana P, Waters J, Berek JS, Woie K, Oza AM, Canzler U, Gil-Martin M, Lesoin A, Monk BJ, Lund B, Gilbert L, Wenham RM, Benigno B, Arora S, Hazard SJ, Mirza MR. Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Nov 10;37(32):2968-2973. doi: 10.1200/JCO.18.02238. Epub 2019 Jun 7.

Results Reference

derived

PubMed Identifier

30026000

Citation

Oza AM, Matulonis UA, Malander S, Hudgens S, Sehouli J, Del Campo JM, Berton-Rigaud D, Banerjee S, Scambia G, Berek JS, Lund B, Tinker AV, Hilpert F, Vazquez IP, D'Hondt V, Benigno B, Provencher D, Buscema J, Agarwal S, Mirza MR. Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2018 Aug;19(8):1117-1125. doi: 10.1016/S1470-2045(18)30333-4. Epub 2018 Jul 17.

Results Reference

derived

PubMed Identifier

29767688

Citation

Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181. Erratum In: Ann Oncol. 2019 May 1;30(5):859.

Results Reference

derived

Links:

URL

http://www.facingourrisk.org

Description

Facing our risk of cancer empowered website

Learn more about this trial

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

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A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Ovarian Neoplasms, Platinum Sensitive Ovarian Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial