Clinical trial NCT01847274: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Neoplasms
Platinum Sensitive Ovarian Cancer
Keywords: ovarian cancer
platinum sensitive
gBRCAmut
BRCA
high-grade serous histology
PARP inhibitor
Lead sponsor: Tesaro, Inc.
Sponsor class: INDUSTRY
Collaborators: name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
name: Myriad Genetics, Inc.
name: US Oncology Research
name: Sarah Cannon
name: Cooperative Ovarian Cancer Group (COGI)
name: Facing Our Risk of Cancer Empowered
First posted: 2013-05-06
Enrollment: 596
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
timeFrame: 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
measure: Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
timeFrame: 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
measure: Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation
timeFrame: 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 outcomes:
measure: Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
timeFrame: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
measure: Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
timeFrame: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
measure: Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)
timeFrame: 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
measure: Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation
timeFrame: 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
measure: Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)
timeFrame: 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
measure: Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
timeFrame: 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
measure: Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
timeFrame: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
measure: Overall Survival in Cohort With No Germline BRCA Mutation
timeFrame: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
measure: Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
timeFrame: 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
measure: Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation
timeFrame: 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
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2
timeFrame: Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
timeFrame: Baseline (pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression
timeFrame: Baseline (Pre-dose on Cycle 1 Day 1, Each cycle was of 28 days) and up to 7 years, 7 months and 4 days
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression
timeFrame: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
measure: Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
measure: Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
measure: Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
measure: Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression
timeFrame: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
measure: Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
measure: Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
measure: Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6
timeFrame: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
measure: Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression
timeFrame: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline
timeFrame: At Baseline
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2
timeFrame: At Cycle 2 (Each cycle was of 28 days)
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4
timeFrame: At Cycle 4 (Each cycle was of 28 days)
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6
timeFrame: At Cycle 6 (Each cycle was of 28 days)
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression
timeFrame: Up to 7 years, 7 months and 4 days
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline
timeFrame: At Baseline
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2
timeFrame: At Cycle 2 (Each cycle was of 28 days)
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4
timeFrame: At Cycle 4 (Each cycle was of 28 days)
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6
timeFrame: At Cycle 6 (Each cycle was of 28 days)
measure: Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression
timeFrame: Up to 7 years, 7 months and 4 days
measure: Number of Participants With Concordance of a Candidate Companion BRAC Analysis Diagnostic Test Compared to the Centralized BRCA Mutation Test Used in This Study
timeFrame: Up to 7 years, 7 months and 4 days
measure: Number of Participants With Concordance of a Candidate Companion HRD Diagnostic Test Compared to the HRD Test Used in This Study
timeFrame: Up to 7 years, 7 months and 4 days
measure: Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: Up to 7 years, 7 months and 6 days
measure: Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)
timeFrame: Up to 8 months, 26 days
measure: Number of Participants With Non-serious AEs and SAEs in FE Sub-study
timeFrame: Up to 2 years, 3 months and 11 days
measure: Number of Participants With Non-serious AEs and SAEs in QTc Sub-study
timeFrame: Up to 5 years 10 months and 22 days
measure: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)
timeFrame: Pre-dose and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
measure: 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)
timeFrame: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)
timeFrame: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
measure: Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)
timeFrame: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
measure: Terminal Elimination Half-life (t1/2) Following Administration of Niraparib (FE Sub-study)
timeFrame: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
measure: Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds
timeFrame: At Baseline (Cycle 1 Day 1, each cycle was of 28 days)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Palo Alto
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: New Haven
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Burlington
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Morristown
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Farmington
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Lake Success
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Vancouver
country: United States
facility: GSK Investigational Site
state: Oregon
city: Abington
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: The Woodlands
country: United States
facility: GSK Investigational Site
state: Texas
city: Graz
country: Austria
facility: GSK Investigational Site
city: Innsbruck
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Edegem
country: Belgium
facility: GSK Investigational Site
city: Kortrijk
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Aalborg
country: Denmark
facility: GSK Investigational Site
city: Copenhagen
country: Denmark
facility: GSK Investigational Site
city: Herlev
country: Denmark
facility: GSK Investigational Site
city: Odense
country: Denmark
facility: GSK Investigational Site
city: Besançon Cedex
country: France
facility: GSK Investigational Site
city: Lille
country: France
facility: GSK Investigational Site
city: Montpellier Cedex 5
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Saint Brieuc
country: France
facility: GSK Investigational Site
city: Saint-Herblain cedex
country: France
facility: GSK Investigational Site
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Goettingen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Szolnok
country: Hungary
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Holon
country: Israel
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: GSK Investigational Site
city: Kfar-Saba
country: Israel
facility: GSK Investigational Site
city: Rehovot
country: Israel
facility: GSK Investigational Site
city: Tel Aviv
country: Israel
facility: GSK Investigational Site
city: Tel Hashomer
country: Israel
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Brescia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Catania
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: MIlano
country: Italy
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
state: Asturias
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Lund
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
state: Nottinghamshire
city: Yeovil
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
state: West Midlands
city: Bebington, Wirral
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Maidstone
country: United Kingdom
facility: GSK Investigational Site
city: Rhyl
country: United Kingdom
facility: GSK Investigational Site
city: Taunton
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Studies
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.