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

• ClinicalTrials.gov Identifier: NCT01847274
• Recruitment Status: Active, not recruiting
• First Posted: May 6, 2013
• Results First Posted: May 1, 2019
• Last Update Posted: October 14, 2020
• 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
• Information provided by (Responsible Party): Tesaro, Inc.

Tracking Information

• First Submitted Date: April 11, 2013
• First Posted Date: May 6, 2013
• Results First Submitted Date: October 18, 2018
• Results First Posted Date: May 1, 2019
• Last Update Posted Date: October 14, 2020
• Actual Study Start Date: June 21, 2013
• Actual Primary Completion Date: April 22, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2019)

• Progression-Free Survival (PFS) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From date of randomization to the earliest date of disease progression or death from any cause. ]
  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.
• Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) [ Time Frame: From date of randomization to the earliest date of disease progression or death from any cause ]
  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.
• Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From date of randomization to the earliest date of disease progression or death from any cause. ]
  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.

Original Primary Outcome Measures (submitted: May 3, 2013)

Progression free survival of ovarian cancer patients [ Time Frame: 35 months ]

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).

Current Secondary Outcome Measures (submitted: May 27, 2020)

• Time to First Subsequent Therapy (TFST) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From date of randomization to the earliest date of first subsequent therapy or death. ]
  Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment. 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 (TFST) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From date of randomization to the earliest date of first subsequent therapy or death. ]
  Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment. 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 (CFI) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment. ]
  CFI 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 (CFI) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment. ]
  CFI 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 (PFS2) in Cohort With Germline BRCA Mutation (gBRCA) [ 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. ]
  Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. PFS2 was defined as the time 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. This study is ongoing, PFS2 is immature at this stage of primary analysis.
• Progression-Free Survival 2 (PFS2) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ 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. ]
  Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. PFS2 was defined as the time 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. This study is ongoing, PFS2 is immature at this stage of primary analysis.
• Overall Survival (OS) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From treatment randomization to date of death by any cause ]
  Patients were to be followed off treatment every 3 months for survival status. Overall survival is defined as the date of randomization to the date of death by any cause. Results not yet reported.
• Overall Survival (OS) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From treatment randomization to date of death by any cause ]
  Patients were to be followed off treatment every 3 months for survival status. Overall survival is defined as the date of randomization to the date of death by any cause. Results not yet reported.
• Time to Second Subsequent Therapy (TSST) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From the date of randomization to the start date of the second subsequent anti-cancer therapy. ]
  Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. TSST is defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death. Results not yet reported.
• Time to Second Subsequent Therapy (TSST) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From the date of randomization to the start date of the second subsequent anti-cancer therapy. ]
  Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. TSST is defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death. Results not yet reported.
• Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA [ Time Frame: At Cycle 2 ]
  The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
• Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA [ Time Frame: At Cycle 4 ]
  The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
• Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA [ Time Frame: At Cycle 6 ]
  The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
• Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA [ Time Frame: At Post Progression ]
  The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
• Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA [ Time Frame: At Cycle 2 ]
  The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
• Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA [ Time Frame: At Cycle 4 ]
  The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
• Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA [ Time Frame: At Cycle 6 ]
  The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
• Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA [ Time Frame: At Post Progression ]
  The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
• Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA [ Time Frame: At Cycle 2 ]
  EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
• Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA [ Time Frame: At Cycle 4 ]
  EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
• Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA [ Time Frame: At Cycle 6 ]
  EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
• Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA [ Time Frame: At Post Progression ]
  EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
• Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA [ Time Frame: At Cycle 2 ]
  EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
• Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA [ Time Frame: At Cycle 4 ]
  EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
• Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA [ Time Frame: At Cycle 6 ]
  EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
• Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA [ Time Frame: At Post Progression ]
  EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.

Original Secondary Outcome Measures (submitted: May 3, 2013)

• Patient Reported Outcomes [ Time Frame: 35 months ]
  Functional Assessment of Cancer therapy - Ovarian Symptom Index (FOSI) EQ-5D-5L Neuropathy Questionnaire
• Progression Free Survival Two [ Time Frame: 35 months ]
  Time from treatment randomization to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death by any cause.
• Chemotherapy Free Interval [ Time Frame: 35 Months ]
  Chemotherapy free interval (CFI) is the time from last platinum dose until initiation of the next anticancer therapy
• Overall Survival of Ovarian Cancer Patients [ Time Frame: 35 Months ]
• Evaluate the safety and tolerability of niraparib in ovarian cancer patients [ Time Frame: 35 months ]
  Review of adverse events, physical exams, electrocardiograms (ECGs), and safety lab values
• BRACA diagnostic test [ Time Frame: 35 months ]
  Concordance of a candidate companion diagnostic test compared to centralized BRCA mutation test

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Ovarian Neoplasms
• Platinum Sensitive Ovarian Cancer

Intervention

• Drug: Active comparator: Niraparib
  Niraparib vs placebo 2:1 ratio
  Other Name: Niraparib
• Drug: placebo

Study Arms

• Active Comparator: Niraparib
  2:1 Ratio administered once daily continuously during a 28 day cycle.
  Intervention: Drug: Active comparator: Niraparib
• Placebo Comparator: Placebo
  Administered once daily continuously over a 28 day cycle.
  Intervention: Drug: placebo

Publications *

• 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, Mądry R, Christensen RD, Berek JS, Dørum A, Tinker AV, du Bois A, González-Martín 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. Epub 2016 Oct 7.
• Mirza MR, Benigno B, Dørum A, Mahner S, Bessette P, Barceló IB, Berton-Rigaud D, Ledermann JA, Rimel BJ, Herrstedt J, Lau S, du Bois A, Herráez 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.
• Matulonis UA, Walder L, Nøttrup TJ, Bessette P, Mahner S, Gil-Martin M, Kalbacher E, Ledermann JA, Wenham RM, Woie K, Lau S, Marmé 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.
• 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.
• 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, Vázquez 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.
• 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. Ann Oncol. 2019 May;30(5):859.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 24, 2020): 578
• Original Estimated Enrollment (submitted: May 3, 2013): 360
• Estimated Study Completion Date: December 14, 2020
• Actual Primary Completion Date: April 22, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Poland, Spain, Sweden, United Kingdom, United States

Administrative Information

• NCT Number: NCT01847274
• Other Study ID Numbers: 213356; PR-30-5011-C ( Other Identifier: Tesaro )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Tesaro, Inc.
• Study 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

Investigators

• Study Director: GSK Clinical Studies; GlaxoSmithKline

• PRS Account: Tesaro, Inc.
• Verification Date: September 2020