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| ID | Type | Description | Link |
|---|---|---|---|
| 3000-02-004 | Other Identifier | Tesaro |
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Niraparib is an oral inhibitor of poly adenosine diphosphate-ribose polymerase (PARP)-1 and PARP-2. This study will evaluate safety and efficacy of niraparib combined with bevacizumab as maintenance treatment in participants with advanced (stage IIIB-IV) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer following front-line platinum-based chemotherapy with bevacizumab. Eligible participants who achieve complete response (CR), partial response (PR), or no evidence of disease (NED) following treatment with platinum-based chemotherapy in addition to bevacizumab will be enrolled in the study and will receive maintenance treatment with niraparib (for up to 3 years) combined with bevacizumab (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first. Participants who have not progressed after 3 years of niraparib maintenance treatment may continue with niraparib beyond 3 years if they are benefiting from treatment, upon consultation with Sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving niraparib+ bevacizumab | Experimental | Participants will be administered bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute (min) intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib will be administered orally once a day continuously throughout each 21-day cycle (84-day cycle after amendment 2). On Day 1 of each cycle, niraparib will be administered upon completion of bevacizumab infusion. The starting dose of niraparib will be based on the participant's Baseline actual body weight or platelet count. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Niraparib will be administered orally once a day continuously throughout each 21 day cycle (84-day cycle after amendment 2). The starting dose of niraparib will be based on the participant's Baseline actual body weight or platelet count. Participants with a Baseline actual body weight of greater than equal to (>=) 77 kg and Baseline platelet count of >=150,000/ microliter (μL) will take 300 mg/day (3X100mg) at each dose administration. Participants with a Baseline actual body weight of less than (<) 77 kg and/or Baseline platelet count of <150,000/μL will take 200 mg (2X100 mg) at each dose administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Rate | PFS rate at 18 months is defined as the percentage of participants who have not progressed or died within 18 months after niraparib combined with bevacizumab treatment initiation. Progression was assessed by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria per Investigator assessment and defined as a 20 percent (%) increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions. Survival rate is the percentage of participants without progression assessed by RECIST v1.1 or death by the landmark timepoint. Confidence intervals was constructed using exact method. | At 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) by RECIST v 1.1 | PFS was defined as the time from treatment initiation with niraparib combined with bevacizumab to the earlier date of assessment of progression, as assessed by RECIST v1.1 criteria, based on Investigator assessment, or death by any cause in the absence of progression. | Up to end of study (approximately 79 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36604 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35690498 | Background | Hardesty MM, Krivak TC, Wright GS, Hamilton E, Fleming EL, Belotte J, Keeton EK, Wang P, Gupta D, Clements A, Gray HJ, Konecny GE, Moore RG, Richardson DL. OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab. Gynecol Oncol. 2022 Aug;166(2):219-229. doi: 10.1016/j.ygyno.2022.05.020. Epub 2022 Jun 9. | |
| 40602355 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Niraparib + Bevacizumab | Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2022 | Jun 23, 2025 |
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This is an open label study
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| Bevacizumab | Biological | Maintenance bevacizumab 15 mg/kg will be administered via a 30-minute IV infusion on Day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Bevacizumab will be administered for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of approximately 5 months of bevacizumab received with chemotherapy. |
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| Overall Survival (OS) | OS was defined as the date of initiation of niraparib treatment in combination with bevacizumab to the date of death by any cause. | Up to end of study (approximately 79 months) |
| RECIST or Cancer Antigen (CA)-125 Progression Free Survival | RECIST or CA-125 progression-free survival is defined as the time from initiation of niraparib treatment in combination with bevacizumab to the earliest date of progression assessed by RECIST v1.1 or CA-125 progression or death by any cause. CA-125 progression is defined as participants with elevated CA-125 pretreatment and normalization of CA-125 that must show evidence of CA-125 ≥ 2 × upper limit of normal (ULN) on 2 occasions at least 1 week apart OR elevated CA-125 pretreatment that never normalizes and must show evidence of CA-125 ≥ 2 × the nadir value on 2 occasions at least 1 week apart OR elevated CA-125 in the normal range pretreatment that must show evidence of CA-125 ≥ 2 × ULN on 2 occasions at least 1 week apart. | Up to end of study (approximately 79 months) |
| Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI) | 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 multiplied by 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). Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1), Cycles 3, 5, 7, 9, 13, 17, 21, 25, 29 (Each Cycle was of 21 days) and end of treatment (70 months) |
| Time to First Subsequent Therapy (TFST) | TFST was defined as the date of initiation of niraparib treatment in combination with bevacizumab treatment in the current study to the start date of the first subsequent anticancer therapy. | Up to end of study (approximately 79 months) |
| Time to Second Subsequent Therapy (TSST) | TSST was defined as the date of initiation of treatment of niraparib in combination with bevacizumab treatment in the current study to the start date of the second subsequent anticancer therapy. | Up to end of study (approximately 79 months) |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Non-serious TEAEs and Treatment-emergent Serious Adverse Events (TESAEs) | Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAEs is any AE that occurred for the first time after at least 1 dose of study treatment administration and until treatment duration. TEAEs which were not serious were considered as non-serious TEAEs. TESAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. Percentages are rounded off to the nearest decimal point. | Up to end of treatment (70 months) |
| Number of Participants With TEAEs Leading to Niraparib Treatment Discontinuation | AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is any AE that occurred for the first time after at least 1 dose of study treatment administration. AEs were coded using the MedDRA coding system. | Up to end of treatment (70 months) |
| Number of Participants With TEAEs Leading to Niraparib Dose Reductions | AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is any AE that occurred for the first time after at least 1 dose of study treatment administration. AEs were coded using the MedDRA coding system. | Up to end of treatment (70 months) |
| Number of Participants With AEs of Special Interest (AESI) | AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs of scientific and medical concern related to the treatment were monitored, and rapidly communicated by investigator to sponsor. AEs were coded using the MedDRA coding system. | Up to end of treatment (70 months) |
| Change From Baseline (CFB) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Change From Baseline (CFB) in Pulse Rate | Pulse Rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Change From Baseline (CFB) in Temperature | Temperature was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Number of Participants Who Used Concomitant Medications | Any permitted concomitant medication(s), including non-prescription medication(s) and herbal product(s), taken during the study were recorded. | Up to end of treatment (70 months) |
| Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils | Blood samples were collected for the assessment of change from Baseline in hematology parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Change From Baseline (CFB) in Hematology Parameter: Hemoglobin (Hb) | Blood samples were collected for the assessment of change from Baseline in hematology parameter. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Change From Baseline (CFB) in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) | Blood samples were collected for the assessment of change from Baseline in hematology parameter. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Blood samples were collected for the assessment of change from Baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Change From Baseline (CFB) in Clinical Chemistry Parameters: Bilirubin and Creatinine | Blood samples were collected for the assessment of change from Baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Change From Baseline (CFB) in Clinical Chemistry Parameters: Albumin and Protein | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Change From Baseline (CFB) in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Baseline (Day 1) and end of treatment (70 months) |
| Anchorage |
| Alaska |
| 99508 |
| United States |
| GSK Investigational Site | Mesa | Arizona | 85284 | United States |
| GSK Investigational Site | Burbank | California | 91505 | United States |
| GSK Investigational Site | Los Angeles | California | 90095 | United States |
| GSK Investigational Site | Fort Myers | Florida | 33908 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33705 | United States |
| GSK Investigational Site | Kansas City | Kansas | 66205 | United States |
| GSK Investigational Site | Detroit | Michigan | 48201 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39216 | United States |
| GSK Investigational Site | Columbia | Missouri | 65212 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64132 | United States |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| GSK Investigational Site | Englewood | New Jersey | 07631 | United States |
| GSK Investigational Site | Morristown | New Jersey | 07962-1956 | United States |
| GSK Investigational Site | Summit | New Jersey | 07962-1956 | United States |
| GSK Investigational Site | Albany | New York | 12208 | United States |
| GSK Investigational Site | Rochester | New York | 14642 | United States |
| GSK Investigational Site | Asheville | North Carolina | 28816 | United States |
| GSK Investigational Site | Columbus | Ohio | 43214 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15224 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02905 | United States |
| GSK Investigational Site | Chattanooga | Tennessee | 37403 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Seattle | Washington | 98109 | United States |
| Derived |
| Hardesty MM, Krivak TC, Wright GS, Hamilton E, Fleming EL, Belotte J, Gorman S, Compton N, Clements A, Gray HJ, Konecny GE, Moore RG, Richardson DL. A phase 2 trial of niraparib plus bevacizumab maintenance therapy following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer: final analysis and overall survival results from OVARIO. Gynecol Oncol. 2025 Aug;199:96-102. doi: 10.1016/j.ygyno.2025.06.014. Epub 2025 Jul 1. |
| 39244209 | Derived | Thaker PH, Areli Calderon Boyle T, Burns S, Lim J, Hartman J, Kalilani LV, Schilder JM, Hurteau JA, Golembesky AK. Characteristics and real-world outcomes of patients with epithelial ovarian cancer who received niraparib plus bevacizumab first-line maintenance therapy in the COMB1NE study. Int J Gynecol Cancer. 2024 Dec 2;34(12):1924-1931. doi: 10.1136/ijgc-2024-005611. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Niraparib + Bevacizumab | Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) Rate | PFS rate at 18 months is defined as the percentage of participants who have not progressed or died within 18 months after niraparib combined with bevacizumab treatment initiation. Progression was assessed by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria per Investigator assessment and defined as a 20 percent (%) increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions. Survival rate is the percentage of participants without progression assessed by RECIST v1.1 or death by the landmark timepoint. Confidence intervals was constructed using exact method. | Intent-to-treat (ITT) Population comprised of all participants who received any amount of niraparib (at least 1 dose). | Posted | Number | 95% Confidence Interval | Percentage of participants | At 18 months |
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| Secondary | Progression Free Survival (PFS) by RECIST v 1.1 | PFS was defined as the time from treatment initiation with niraparib combined with bevacizumab to the earlier date of assessment of progression, as assessed by RECIST v1.1 criteria, based on Investigator assessment, or death by any cause in the absence of progression. | ITT Population | Posted | Median | 95% Confidence Interval | Months | Up to end of study (approximately 79 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the date of initiation of niraparib treatment in combination with bevacizumab to the date of death by any cause. | ITT Population | Posted | Median | 95% Confidence Interval | Months | Up to end of study (approximately 79 months) |
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| Secondary | RECIST or Cancer Antigen (CA)-125 Progression Free Survival | RECIST or CA-125 progression-free survival is defined as the time from initiation of niraparib treatment in combination with bevacizumab to the earliest date of progression assessed by RECIST v1.1 or CA-125 progression or death by any cause. CA-125 progression is defined as participants with elevated CA-125 pretreatment and normalization of CA-125 that must show evidence of CA-125 ≥ 2 × upper limit of normal (ULN) on 2 occasions at least 1 week apart OR elevated CA-125 pretreatment that never normalizes and must show evidence of CA-125 ≥ 2 × the nadir value on 2 occasions at least 1 week apart OR elevated CA-125 in the normal range pretreatment that must show evidence of CA-125 ≥ 2 × ULN on 2 occasions at least 1 week apart. | ITT Population | Posted | Median | 95% Confidence Interval | Months | Up to end of study (approximately 79 months) |
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| Secondary | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI) | 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 multiplied by 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). Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | ITT Population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Scores on scale | Baseline (Day 1), Cycles 3, 5, 7, 9, 13, 17, 21, 25, 29 (Each Cycle was of 21 days) and end of treatment (70 months) |
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| Secondary | Time to First Subsequent Therapy (TFST) | TFST was defined as the date of initiation of niraparib treatment in combination with bevacizumab treatment in the current study to the start date of the first subsequent anticancer therapy. | ITT Population | Posted | Median | 95% Confidence Interval | Months | Up to end of study (approximately 79 months) |
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| Secondary | Time to Second Subsequent Therapy (TSST) | TSST was defined as the date of initiation of treatment of niraparib in combination with bevacizumab treatment in the current study to the start date of the second subsequent anticancer therapy. | ITT Population | Posted | Median | 95% Confidence Interval | Months | Up to end of study (approximately 79 months) |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Non-serious TEAEs and Treatment-emergent Serious Adverse Events (TESAEs) | Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAEs is any AE that occurred for the first time after at least 1 dose of study treatment administration and until treatment duration. TEAEs which were not serious were considered as non-serious TEAEs. TESAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. Percentages are rounded off to the nearest decimal point. | Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). | Posted | Number | Percentage of participants | Up to end of treatment (70 months) |
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| Secondary | Number of Participants With TEAEs Leading to Niraparib Treatment Discontinuation | AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is any AE that occurred for the first time after at least 1 dose of study treatment administration. AEs were coded using the MedDRA coding system. | Safety Population | Posted | Count of Participants | Participants | Up to end of treatment (70 months) |
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| Secondary | Number of Participants With TEAEs Leading to Niraparib Dose Reductions | AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is any AE that occurred for the first time after at least 1 dose of study treatment administration. AEs were coded using the MedDRA coding system. | Safety Population | Posted | Count of Participants | Participants | Up to end of treatment (70 months) |
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| Secondary | Number of Participants With AEs of Special Interest (AESI) | AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs of scientific and medical concern related to the treatment were monitored, and rapidly communicated by investigator to sponsor. AEs were coded using the MedDRA coding system. | Safety Population | Posted | Count of Participants | Participants | Up to end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety Population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline (Day 1) and end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Pulse Rate | Pulse Rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety Population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Beats/minute | Baseline (Day 1) and end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Temperature | Temperature was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety Population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Celsius | Baseline (Day 1) and end of treatment (70 months) |
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| Secondary | Number of Participants Who Used Concomitant Medications | Any permitted concomitant medication(s), including non-prescription medication(s) and herbal product(s), taken during the study were recorded. | Safety Population | Posted | Count of Participants | Participants | Up to end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils | Blood samples were collected for the assessment of change from Baseline in hematology parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Giga cells per liter (10^9 cells/L) | Baseline (Day 1) and end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Hematology Parameter: Hemoglobin (Hb) | Blood samples were collected for the assessment of change from Baseline in hematology parameter. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Baseline (Day 1) and end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) | Blood samples were collected for the assessment of change from Baseline in hematology parameter. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Femtoliters (fL) | Baseline (Day 1) and end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Blood samples were collected for the assessment of change from Baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline (Day 1) and end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Clinical Chemistry Parameters: Bilirubin and Creatinine | Blood samples were collected for the assessment of change from Baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Micromoles per liter (umol/L) | Baseline (Day 1) and end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Clinical Chemistry Parameters: Albumin and Protein | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Baseline (Day 1) and end of treatment (70 months) |
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| Secondary | Change From Baseline (CFB) in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | International units per Liter (IU/L) | Baseline (Day 1) and end of treatment (70 months) |
|
|
All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Niraparib + Bevacizumab | Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion. | 56 | 105 | 32 | 105 | 105 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune system disorders | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Endocrine disorders | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2024 | Jun 23, 2025 | SAP_003.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C545685 | niraparib |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Asian |
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| American Indian or Alaska Native |
|
| Unknown |
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