Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Ovarian Cancer Clinical Trial

Official title:

A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866697
• Other study ID #: 110655
• Secondary ID: 2008-004672-50CP
• Status: Completed
• Phase: Phase 3
• Start date: May 26, 2009
• Est. completion date: August 24, 2017

Study information

• Verified date: January 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.

Description:

This was a randomized, two-arm, placebo controlled, double-blind, multicenter, intergroup Phase III study in women with non-bulky FIGO (International Federation of Gynecology and Obstetrics) Stage II - IV ovarian, fallopian tube, or primary peritoneal cancer that had not progressed (i.e., complete response (CR), partial response (PR), stable disease (SD) after completing their first-line chemotherapy for advanced ovarian cancer. Approximately 900 subjects were to be enrolled into the study. Study was closed following 3rd overall survival (OS) interim analysis as planned per protocol, which confirmed futility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 940
• Est. completion date: August 24, 2017
• Est. primary completion date: July 8, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• written informed consent
• At least 18 years old.
• Histologically confirmed, FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy.
• Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
• No evidence of disease progression
• ECOG status of 0 or 2
• Able to swallow and retain oral medication.
• Adequate hematologic, hepatic, and renal system function as follows:

Hematologic

• Absolute neutrophil count (ANC) at least 1.5 X 10^9/L
• Hemoglobin at least 9 g/dL (or 5.59 mmol/L)
• Platelets at least 100 X 10^9/L
• Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN
• Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic
• Total bilirubin up to 1.5 X ULN
• AST and ALT up to 2.5 X ULN Renal
• Serum creatinine up to 1.5 mg/dL Or, if greater than 1.5 mg/dL: Calculated creatinine clearance at least 50 mL/min Urine Protein
• Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24- hour urine protein analysis.
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception.

Exclusion Criteria:

• Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy
• Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met.
• Clinically significant gastrointestinal abnormalities
• Prolongation of corrected QT interval (QTc) > 480 msecs
• History of any one or more cardiovascular conditions within the past 6 months prior to randomization
• Cardiac angioplasty or stenting
• Myocardial infarction
• Unstable angina
• Symptomatic peripheral vascular disease
• Class III or IV congestive heart failure
• Poorly controlled hypertension
• History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization
• Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer.
• Evidence of active bleeding or bleeding diathesis.
• Hemoptysis within 6 weeks prior to randomization.
• Endobronchial metastases.
• Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
• Investigational or anti-VEGF anticancer therapy prior to study randomization.
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
• Invasive malignancies that showed activity of disease within 5 years prior to randomization

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Pazopanib
Pazopanib 800 mg tablet daily for 104 weeks (24 months)
• Placebo
Matching placebo 800 mg tablet daily, for 104 weeks (24 months).

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Camperdown	New South Wales
Australia	Novartis Investigative Site	Herston	Queensland
Australia	Novartis Investigative Site	Hobart	Tasmania
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	Malvern	Victoria
Australia	Novartis Investigative Site	Melbourne
Australia	Novartis Investigative Site	Nedlands	Western Australia
Australia	Novartis Investigative Site	Parkville	Victoria
Australia	Novartis Investigative Site	Randwick	New South Wales
Australia	Novartis Investigative Site	South Brisbane	Queensland
Australia	Novartis Investigative Site	Waratah	New South Wales
Australia	Novartis Investigative Site	Wodonga	Victoria
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Innsbruck
Austria	Novartis Investigative Site	Klagenfurt Am Woerthersee
Austria	Novartis Investigative Site	Korneuburg
Austria	Novartis Investigative Site	Krems
Austria	Novartis Investigative Site	Leoben
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Oberpullendorf
Austria	Novartis Investigative Site	Wien
Austria	Novartis Investigative Site	Wien
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Bonheiden
Belgium	Novartis Investigative Site	Duffel
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Kortrijk
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Libramont
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Namur
Belgium	Novartis Investigative Site	Oostende
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Jinan	Shandong
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Tianjin
Denmark	Novartis Investigative Site	Aalborg
Denmark	Novartis Investigative Site	Herlev
Denmark	Novartis Investigative Site	Herning
Denmark	Novartis Investigative Site	Koebenhavn Oe
France	Novartis Investigative Site	ANGERS Cedex 2
France	Novartis Investigative Site	Avignon cedex
France	Novartis Investigative Site	Besancon Cedex
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Bourg en Bresse Cedex
France	Novartis Investigative Site	Brest Cedex
France	Novartis Investigative Site	Brive La Gaillarde
France	Novartis Investigative Site	Caen Cedex 05
France	Novartis Investigative Site	Clermont-Ferrand cedex
France	Novartis Investigative Site	Colmar Cedex
France	Novartis Investigative Site	Dax Cedex
France	Novartis Investigative Site	Grenoble Cedex
France	Novartis Investigative Site	Grenoble Cedex 09
France	Novartis Investigative Site	La Roche sur Yon Cedex 9
France	Novartis Investigative Site	Le Chesnay Cedex
France	Novartis Investigative Site	Le Mans
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Lorient cedex
France	Novartis Investigative Site	Lyon Cedex 08
France	Novartis Investigative Site	Marseille cedex
France	Novartis Investigative Site	Metz Cedex 03
France	Novartis Investigative Site	Mont de Marsan
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Mougins Cedex 2
France	Novartis Investigative Site	Nancy
France	Novartis Investigative Site	Nantes Cedex 2
France	Novartis Investigative Site	Nice Cedex 2
France	Novartis Investigative Site	Nimes
France	Novartis Investigative Site	Orleans
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris cedex 05
France	Novartis Investigative Site	Paris Cedex 10
France	Novartis Investigative Site	Paris Cedex 20
France	Novartis Investigative Site	Paris Cedex 4
France	Novartis Investigative Site	Perigueux Cedex
France	Novartis Investigative Site	Perin Sur Mer
France	Novartis Investigative Site	Pierre-Benite Cedex
France	Novartis Investigative Site	Reims Cedex
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	Saint-Herblain
France	Novartis Investigative Site	Saint-Priest en Jarez
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Strasbourg Cedex
France	Novartis Investigative Site	Suresnes
France	Novartis Investigative Site	Thonon-les-Bains
France	Novartis Investigative Site	Vandoeuvre-Les-Nancy
Germany	Novartis Investigative Site	Bayreuth	Bayern
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Bonn	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Bonn	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Bonn	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Braunschweig	Niedersachsen
Germany	Novartis Investigative Site	Chemnitz	Sachsen
Germany	Novartis Investigative Site	Coburg	Bayern
Germany	Novartis Investigative Site	Cuxhaven	Niedersachsen
Germany	Novartis Investigative Site	Darmstadt	Hessen
Germany	Novartis Investigative Site	Deggendorf	Bayern
Germany	Novartis Investigative Site	Detmold	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Dortmund	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Dresden	Sachsen
Germany	Novartis Investigative Site	Dresden	Sachsen
Germany	Novartis Investigative Site	Duesseldorf	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Ebersberg	Bayern
Germany	Novartis Investigative Site	Eggenfelden	Bayern
Germany	Novartis Investigative Site	Essen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Essen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Essen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Esslingen	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Flensburg	Schleswig-Holstein
Germany	Novartis Investigative Site	Frankfurt	Hessen
Germany	Novartis Investigative Site	Frankfurt am Main	Hessen
Germany	Novartis Investigative Site	Freiburg	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Freiburg	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Fuerth	Bayern
Germany	Novartis Investigative Site	Fulda	Hessen
Germany	Novartis Investigative Site	Georgsmarienhuette	Niedersachsen
Germany	Novartis Investigative Site	Gera	Thueringen
Germany	Novartis Investigative Site	Gifhorn	Niedersachsen
Germany	Novartis Investigative Site	Goettingen	Niedersachsen
Germany	Novartis Investigative Site	Goslar	Niedersachsen
Germany	Novartis Investigative Site	Greifswald	Mecklenburg-Vorpommern
Germany	Novartis Investigative Site	Halle	Sachsen-Anhalt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Hildesheim	Niedersachsen
Germany	Novartis Investigative Site	Karlsruhe	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Karlsruhe	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Kassel	Hessen
Germany	Novartis Investigative Site	Kiel	Schleswig-Holstein
Germany	Novartis Investigative Site	Koeln	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Leer	Niedersachsen
Germany	Novartis Investigative Site	Leipzg	Sachsen
Germany	Novartis Investigative Site	Lich	Hessen
Germany	Novartis Investigative Site	Limburg	Hessen
Germany	Novartis Investigative Site	Luebeck	Schleswig-Holstein
Germany	Novartis Investigative Site	Lueneburg	Niedersachsen
Germany	Novartis Investigative Site	Magdeburg	Sachsen-Anhalt
Germany	Novartis Investigative Site	Magdeburg	Sachsen-Anhalt
Germany	Novartis Investigative Site	Mainz	Rheinland-Pfalz
Germany	Novartis Investigative Site	Mannheim	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Marburg	Hessen
Germany	Novartis Investigative Site	Muenchen	Bayern
Germany	Novartis Investigative Site	Muenchen	Bayern
Germany	Novartis Investigative Site	Muenchen	Bayern
Germany	Novartis Investigative Site	Mutlangen	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Neuss	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Nordhausen	Thueringen
Germany	Novartis Investigative Site	Offenbach	Hessen
Germany	Novartis Investigative Site	Offenbach	Hessen
Germany	Novartis Investigative Site	Oldenburg	Niedersachsen
Germany	Novartis Investigative Site	Quedlinburg	Sachsen-Anhalt
Germany	Novartis Investigative Site	Radebeul	Sachsen
Germany	Novartis Investigative Site	Reutlingen	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Rostock	Mecklenburg-Vorpommern
Germany	Novartis Investigative Site	Salzgitter	Niedersachsen
Germany	Novartis Investigative Site	Salzwedel	Sachsen-Anhalt
Germany	Novartis Investigative Site	Schwaebisch Hall	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Schweinfurt	Bayern
Germany	Novartis Investigative Site	Suhl	Thueringen
Germany	Novartis Investigative Site	Trier	Rheinland-Pfalz
Germany	Novartis Investigative Site	Troisdorf	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Tuebingen	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Ulm	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Viersen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Wiesbaden	Hessen
Germany	Novartis Investigative Site	Wiesbaden	Hessen
Germany	Novartis Investigative Site	Wolfsburg	Niedersachsen
Germany	Novartis Investigative Site	Zwickau	Sachsen
Hong Kong	Novartis Investigative Site	Hong Kong
Hong Kong	Novartis Investigative Site	Kowloon
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Waterford
Ireland	Novartis Investigative Site	Wilton, Cork
Italy	Novartis Investigative Site	Avellino	Campania
Italy	Novartis Investigative Site	Aviano (PN)	Friuli-Venezia-Giulia
Italy	Novartis Investigative Site	Bari	Puglia
Italy	Novartis Investigative Site	Bologna	Emilia-Romagna
Italy	Novartis Investigative Site	Bologna	Emilia-Romagna
Italy	Novartis Investigative Site	Brescia	Lombardia
Italy	Novartis Investigative Site	Campobasso	Molise
Italy	Novartis Investigative Site	Carpi (MO)	Emilia-Romagna
Italy	Novartis Investigative Site	Como	Lombardia
Italy	Novartis Investigative Site	Faenza (RA)	Emilia-Romagna
Italy	Novartis Investigative Site	Milano	Lombardia
Italy	Novartis Investigative Site	Milano	Lombardia
Italy	Novartis Investigative Site	Milano	Lombardia
Italy	Novartis Investigative Site	Milano	Lombardia
Italy	Novartis Investigative Site	Milano	Lombardia
Italy	Novartis Investigative Site	Monza	Lombardia
Italy	Novartis Investigative Site	Napoli	Campania
Italy	Novartis Investigative Site	Palermo	Sicilia
Italy	Novartis Investigative Site	Perugia	Umbria
Italy	Novartis Investigative Site	Potenza	Basilicata
Italy	Novartis Investigative Site	Reggio Emilia	Emilia-Romagna
Italy	Novartis Investigative Site	Roma	Lazio
Italy	Novartis Investigative Site	Roma	Lazio
Italy	Novartis Investigative Site	Roma	Lazio
Italy	Novartis Investigative Site	Sondrio	Lombardia
Italy	Novartis Investigative Site	Torino	Piemonte
Italy	Novartis Investigative Site	Torino	Piemonte
Italy	Novartis Investigative Site	Varese	Lombardia
Italy	Novartis Investigative Site	Vicenza	Veneto
Japan	Novartis Investigative Site	Ehime
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hokkaido
Japan	Novartis Investigative Site	Iwate
Japan	Novartis Investigative Site	Kagoshima
Japan	Novartis Investigative Site	Miyagi
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tottori
Korea, Republic of	Novartis Investigative Site	Goyang-si, Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Kangnam-Ku ,Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Norway	Novartis Investigative Site	Bergen
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Stavanger
Norway	Novartis Investigative Site	Tromso
Spain	Novartis Investigative Site	Alcorcon (Madrid)
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Cartagena (Murcia)
Spain	Novartis Investigative Site	Elche
Spain	Novartis Investigative Site	Lerida
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Murcia (El Palmar)
Spain	Novartis Investigative Site	Palma de Mallorca
Spain	Novartis Investigative Site	Pamplona
Spain	Novartis Investigative Site	Sabadell (Barcelona)
Spain	Novartis Investigative Site	San Sebastian
Spain	Novartis Investigative Site	Santiago de Compostela
Spain	Novartis Investigative Site	Terrassa
Spain	Novartis Investigative Site	Valencia
Spain	Novartis Investigative Site	Valencia
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Linkoping
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Uppsala
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
United States	Novartis Investigative Site	Anaheim	California
United States	Novartis Investigative Site	Annandale	Virginia
United States	Novartis Investigative Site	Augusta	Georgia
United States	Novartis Investigative Site	Baldwin Park	California
United States	Novartis Investigative Site	Bellflower	California
United States	Novartis Investigative Site	Bronx	New York
United States	Novartis Investigative Site	Duarte	California
United States	Novartis Investigative Site	Fontana	California
United States	Novartis Investigative Site	Hayward	California
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Irvine	California
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Morristown	New Jersey
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Oakland	California
United States	Novartis Investigative Site	Ontario	California
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Panorama City	California
United States	Novartis Investigative Site	Riverside	California
United States	Novartis Investigative Site	Roseville	California
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Francisco	California
United States	Novartis Investigative Site	San Jose	California
United States	Novartis Investigative Site	Santa Clara	California
United States	Novartis Investigative Site	South San Francisco	California
United States	Novartis Investigative Site	Vallejo	California
United States	Novartis Investigative Site	Walnut Creek	California
United States	Novartis Investigative Site	Woodland Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  China,  Denmark,  France,  Germany,  Hong Kong,  Ireland,  Italy,  Japan,  Korea, Republic of,  Norway,  Spain,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator-assessed Progression-free Survival (PFS)	PFS is the interval between the date of randomization and the date of progression, defined by Response Evaluation Criteria in Solid Tumors (RECIST), or death due to any cause. Per RECIST, for target lesions (TLs), disease progression (PD) is defined as >=20% increase in the sum of the longest diameters (LD) of TLs, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions. For non-target lesions (NTLs), PD is defined as the appearance of >=1 new lesions and/or unequivocal progression of existing NTLs. Participants (par.) who did not progress/die were censored at the date of last adequate assessment (LAA). Par. who started a new anti-cancer therapy (ACT) prior to radiological progression/death were censored at the date of LAA prior to the new ACT. Par. who progressed/died after an extended period (>=12 months) without adequate assessment (AA) were censored at the date of their last visit with AA prior to progression/death.	From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)
Secondary	Overall Survival - Median	Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.	From the date of randomization until the date of death due to any cause up to approximately 25 months
Secondary	Overall Survival: Number of Participants Experiencing Death	Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.	From the date of randomization until the date of death due to any cause up to approximately 25 months
Secondary	Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria	Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause. Progression is defined according to RECIST but can also be based upon serum CA-125. Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 >=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par. with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 >=2x the nadir value on two occasions at least one week apart or; (3) par. with CA-125 in the normal range pretreatment must show evidence of CA-125 >=2x the UNL on two occasions at least one week apart.	From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)
Secondary	3-year Progression-free Survival	3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization. Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause. Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.	Up to 3 years after randomization
Secondary	Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life. Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 ("poor" to "excellent"). Participants were asked to respond to the following questions using the 7-item Likert scale: "How would you rate your overall health during the past week"; "How would you rate your overall quality of life during the past week?" Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA).	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses attitude to disease/treatment functional symptoms, among others. Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses body image symptoms, among others. Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?; Have you been dissatisfied with your body? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25	The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses peripheral neuropathy symptoms, among others. Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25	The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?; Did you experience any change in bowel habit as a result of your disease or treatment?; Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25	The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses hormonal/menopausal symptoms, among others. Participants were asked to indicate the extent to which they experienced hormonal/menopausal symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have hot flashes?; Did you have night sweats? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses sexual functioning symptoms, among others. Participants were asked to indicate the extent to which they experienced sexual functioning problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: To what extent were you interested in sex?; To what extent were you sexually active?; If sexually active, to what extent was sex enjoyable for you?; If sexually active, did you have a dry vagina during sexual activity? Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25	The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses other chemotherapy SE symptoms, among others. Participants were asked to indicate the extent to which they experienced other chemotherapy SE symptoms/problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you lost any hair?; If yes, were you upset by the loss of your hair?; Did food/drink taste different from usual?; Did you have aches or pains in your muscles or joints?; Did you have problems with hearing?; Did you urinate frequently?; Have you had skin problems (e.g., itchy, dry)? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25	The EuroQol (EQ-5D) questionnaire is a 2-page, generic, preference-based quality of life measure comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score The thermometer score is based on a vertical VAS. The VAS is designed like a thermometer scale on which the best health state the participant can imagine is referenced at 100, and the worst health state the participant can imagine is marked by 0. Based on how good or bad the current health state is, the participant is asked to draw a line across the thermometer scale. For example, a line drawn across 46 on the scale of 0 to 100 would be coded 46. A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25	The EQ-5D utility score captures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and/or depression. Participants indicated the level of perceived problems in each of the five dimensions on three levels: 1, no problems; 2, some problems; 3, an extreme problem. Unique health states were defined by combining response levels from each of the five dimensions. For example, state 11111 indicates no problem on any of the five dimensions, whereas state 11223 indicates no problems with mobility or self-care; some problems with performing usual activities, moderate pain/discomfort; and extreme anxiety/depression. Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.	Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary	Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.	From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Secondary	Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade	Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0. WBC=White blood cell.	From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Secondary	Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade	Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0.	From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Secondary	Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)	Participants were assessed for thyroid function abnormalities. Clinical hypothyroidism is defined as 5	From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)