A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Ovarian Neoplasms Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02655016
• Other study ID #: 213359
• Secondary ID: PR-30-5017-C
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 11, 2016
• Est. completion date: September 25, 2024

Study information

• Verified date: March 2024
• Source: Tesaro, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 733
• Est. completion date: September 25, 2024
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Participants must have histologically diagnosed high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to Federation Internationale de Gynécologie et d'Obstétrique (FIGO) criteria.

• Participants with inoperable Stage III and IV disease; All Stage IV participants with operable disease; Participants with stage III or IV disease treated with neoadjuvant chemotherapy and interval debulking surgery; and Participants with stage III disease who have visible residual disease after primary debulking surgery.

• Participants who have received intraperitoneal chemotherapy; All participants must have had more than or equal to (>=)6 and less than or equal to (<=)9 cycles of platinum-based therapy; Participants must have had >=2 post-operative cycles of platinum-based therapy following interval debulking surgery; Participants must have physician assessed Complete response (CR) or Partial response (PR) after >=3 cycles of therapy; and Participants must have either Cancer antigen 125 (CA-125) in the normal range or CA-125 decrease by more than 90 percent(%) during their front-line therapy that is stable for at least 7 days (no increase more than (>)15% from nadir).

• Participants must be randomized within 12 weeks of the first day of the last cycle of chemotherapy.

• All participants must agree to undergo central tumor HRD testing.

• Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin [hCG]) within 7 days prior to receiving the first dose of study treatment.

Exclusion criteria:

• Participant has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer.

• Participants with Stage III disease who have had complete cytoreduction (no visible residual disease) after primary debulking surgery.

• Participant has undergone more than two debulking surgeries for the study disease.

• Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for up to 180 days after the last dose of study treatment.

• Participant has a known hypersensitivity to the components of niraparib or its excipients.

• Participant has received prior treatment with a known PARP inhibitor or has participated in a study where any treatment arm included administration of a known PARP inhibitor.

• Participant is to receive bevacizumab as maintenance treatment.

• Participant has had investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.

• Participant has had any known >=Grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted >4 weeks.

• Participant has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the participation for the full duration of the study treatment, including:

1. Participant received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment.

2. Participant received colony-stimulating factors (e.g., granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment.

• Participant has been diagnosed and/or treated for invasive cancer less than 5 years prior to study enrollment.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• Niraparib
Niraparib will be administered.
• Placebo
Placebo will be administered.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bonheiden
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Charleroi
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Hasselt
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Libramont
Belgium	GSK Investigational Site	Namur
Belgium	GSK Investigational Site	Sint-Niklaas
Canada	GSK Investigational Site	Barrie	Ontario
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montréal	Quebec
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Vancouver	British Columbia
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Ostrava
Czechia	GSK Investigational Site	Plzen-Lochotin
Czechia	GSK Investigational Site	Prague
Czechia	GSK Investigational Site	Prague
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Herlev
Denmark	GSK Investigational Site	Koebenhavn Oe
Denmark	GSK Investigational Site	Odense
Finland	GSK Investigational Site	Kuopio
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
France	GSK Investigational Site	Angers
France	GSK Investigational Site	Caen Cedex 05
France	GSK Investigational Site	Montpellier Cedex 5
France	GSK Investigational Site	Nice Cedex 2
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Pierre-Benite cedex
France	GSK Investigational Site	Rennes Cedex
France	GSK Investigational Site	Saint-Herblain
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Fuerth	Bayern
Germany	GSK Investigational Site	Goettingen	Niedersachsen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Gyor
Ireland	GSK Investigational Site	Galway
Ireland	GSK Investigational Site	Waterford
Israel	GSK Investigational Site	Beer Sheva
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Holon
Israel	GSK Investigational Site	Tel Aviv
Israel	GSK Investigational Site	Tel Hashomer
Italy	GSK Investigational Site	Candiolo (TO)	Piemonte
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Mirano	Veneto
Italy	GSK Investigational Site	Modena	Emilia-Romagna
Italy	GSK Investigational Site	Napoli	Campania
Norway	GSK Investigational Site	Oslo
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Poznan
Russian Federation	GSK Investigational Site	Arkhangelsk
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Irkutsk
Russian Federation	GSK Investigational Site	Ivanovo
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Krasnoyarsk
Russian Federation	GSK Investigational Site	Orenburg
Russian Federation	GSK Investigational Site	Pyatigorsk
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	St-Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Cordoba
Spain	GSK Investigational Site	Elche
Spain	GSK Investigational Site	Girona
Spain	GSK Investigational Site	Hospitalet de Llobregat, Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	San Sebastián
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Zaragoza
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Uppsala
Switzerland	GSK Investigational Site	Basel
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Frauenfeld
Switzerland	GSK Investigational Site	Zurich
Ukraine	GSK Investigational Site	Dnipro
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Ivano-Frankivsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kherson
Ukraine	GSK Investigational Site	Krivoy Rog
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Vinnitsia
Ukraine	GSK Investigational Site	Zaporizhzhia
United Kingdom	GSK Investigational Site	Bath	Somerset
United Kingdom	GSK Investigational Site	Blackburn
United Kingdom	GSK Investigational Site	Exeter
United Kingdom	GSK Investigational Site	Glasgow
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Portsmouth	Hampshire
United Kingdom	GSK Investigational Site	Sheffield
United Kingdom	GSK Investigational Site	Stoke-on-Trent	Staffordshire
United Kingdom	GSK Investigational Site	Truro
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Burlington	Massachusetts
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Covington	Louisiana
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Grand Rapids	Michigan
United States	GSK Investigational Site	Harrison	New York
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	Hinsdale	Illinois
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Kennewick	Washington
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Mayfield Heights	Ohio
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Middletown	New Jersey
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Morgantown	West Virginia
United States	GSK Investigational Site	Neptune	New Jersey
United States	GSK Investigational Site	New Haven	Connecticut
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Rosa	California
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Silver Spring	Maryland
United States	GSK Investigational Site	Sioux Falls	South Dakota
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Oregon
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	Teaneck	New Jersey
United States	GSK Investigational Site	The Woodlands	Texas
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Warrenville	Illinois
United States	GSK Investigational Site	Willow Grove	Pennsylvania
United States	GSK Investigational Site	Wilmington	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Tesaro, Inc.	European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group, Myriad Genetics, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  Switzerland,  Ukraine,  United Kingdom, 

References & Publications (3)

Barretina-Ginesta MP, Monk BJ, Han S, Pothuri B, Auranen A, Chase DM, Lorusso D, Anderson C, Abadie-Lacourtoisie S, Cloven N, Braicu EI, Amit A, Redondo A, Shah R, Kebede N, Hawkes C, Gupta D, Woodward T, O'Malley DM, Gonzalez-Martin A. Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial. Ther Adv Med Oncol. 2022 Sep 22;14:17588359221126149. doi: 10.1177/17588359221126149. eCollection 2022. — View Citation

Gonzalez-Martin A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Perez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28. — View Citation

Lorusso D, Guy H, Samyshkin Y, Hawkes C, Estenson K, Coleman RL. Feasibility Study of a Network Meta-Analysis and Unanchored Population-Adjusted Indirect Treatment Comparison of Niraparib, Olaparib, and Bevacizumab as Maintenance Therapies in Patients with Newly Diagnosed Advanced Ovarian Cancer. Cancers (Basel). 2022 Mar 2;14(5):1285. doi: 10.3390/cancers14051285. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE	An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.	Up to 34 months
Other	Area Under the Curve (AUC) From 0 to the Last Quantifiable Concentration (AUC[0-last])	Blood samples were planned to be collected for assessment of AUC(0-last).	Up to 34 months
Other	Peak Plasma Concentration (Cmax)	Blood samples were planned to be collected for assessment of Cmax.	Up to 34 months
Other	Number of Participants With Positive HRD Test	Number of participants with positive HRD test was planned to be assessed.	Up to 34 months
Primary	Progression Free Survival	Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.	Up to 34 months
Secondary	Overall Survival	Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis.	Up to 34 months
Secondary	Time to First Subsequent Therapy (TFST)	Time to first subsequent therapy was defined as the time from the date of randomization to the date of the first subsequent anti-cancer therapy or death, whichever occurs first. Median and 95% CI are presented.	Up to 34 months
Secondary	Progression-Free Survival-2 (PFS2)	PFS2 was defined as the time from the date of randomization to the date of progression on the next anti-cancer therapy following study treatment or death by any cause, whichever occurs first. Median and 95% CI are presented.	Up to 34 months
Secondary	Change From Baseline in Participant Reported Outcome (PRO): 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)*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). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).	Baseline (Day 1, Pre-dose) and Up to Week 24
Secondary	Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score	The EQ-5D-5L is a well-validated general preference-based, health-related QoL instrument. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).	Baseline (Day 1, Pre-dose) and Up to Week 24
Secondary	Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)	EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Five functional scales had total 15 items (physical-5, role-2, cognitive-4, emotional-2, and social-2). Each functional scales score was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).	Baseline (Day 1, Pre-dose) and Up to Week 24
Secondary	Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30	EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. A global health status/QoL scale had total 2 items. Each global health status/QoL scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 6*100). The global health status/QoL scales range in score from 0 to 100. Higher score represents a higher ("better") level of health status/QoL. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).	Baseline (Day 1, Pre-dose) and Up to Week 24
Secondary	Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30	EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Symptom scale had total 7 items (fatigue-3, pain-2, nausea/vomiting-2). Each symptoms scales and 6 single additional symptoms items score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales and 6 single additional symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).	Baseline (Day 1, Pre-dose) and Up to Week 24
Secondary	Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)	EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/gastrointestinal [GI] symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).	Baseline (Day 1, Pre-dose) and Up to 34 months
Secondary	Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28	EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/GI symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Symptoms scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).	Baseline (Day 1, Pre-dose) and Up to 34 months