Clinical trial NCT00866697: Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: fallopian tube cancer
pazopanib
anti-angiogenesis
ovarian cancer
primary peritoneal cancer
tyrosine kinase inhibitors
gynecologic cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-03-20
Enrollment: 940
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Investigator-assessed Progression-free Survival (PFS)
timeFrame: 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 outcomes:
measure: Overall Survival - Median
timeFrame: From the date of randomization until the date of death due to any cause up to approximately 25 months
measure: Overall Survival: Number of Participants Experiencing Death
timeFrame: From the date of randomization until the date of death due to any cause up to approximately 25 months
measure: Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria
timeFrame: 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)
measure: 3-year Progression-free Survival
timeFrame: Up to 3 years after randomization
measure: 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
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: 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
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: 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
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: 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
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: 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
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25
timeFrame: Baseline; Week 13; Months 7, 10, 13, 16, and 25
measure: Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm
timeFrame: 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)
measure: Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade
timeFrame: 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)
measure: Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade
timeFrame: 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)
measure: Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)
timeFrame: 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)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novartis Investigative Site
state: California
city: Baldwin Park
country: United States
facility: Novartis Investigative Site
state: California
city: Bellflower
country: United States
facility: Novartis Investigative Site
state: California
city: Duarte
country: United States
facility: Novartis Investigative Site
state: California
city: Fontana
country: United States
facility: Novartis Investigative Site
state: California
city: Hayward
country: United States
facility: Novartis Investigative Site
state: California
city: Irvine
country: United States
facility: Novartis Investigative Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Oakland
country: United States
facility: Novartis Investigative Site
state: California
city: Ontario
country: United States
facility: Novartis Investigative Site
state: California
city: Orange
country: United States
facility: Novartis Investigative Site
state: California
city: Panorama City
country: United States
facility: Novartis Investigative Site
state: California
city: Riverside
country: United States
facility: Novartis Investigative Site
state: California
city: Roseville
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Francisco
country: United States
facility: Novartis Investigative Site
state: California
city: San Jose
country: United States
facility: Novartis Investigative Site
state: California
city: Santa Clara
country: United States
facility: Novartis Investigative Site
state: California
city: South San Francisco
country: United States
facility: Novartis Investigative Site
state: California
city: Vallejo
country: United States
facility: Novartis Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigative Site
state: California
city: Woodland Hills
country: United States
facility: Novartis Investigative Site
state: California
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Morristown
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Bronx
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Annandale
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Camperdown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Liverpool
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Randwick
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Waratah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Herston
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: South Brisbane
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Hobart
country: Australia
facility: Novartis Investigative Site
state: Tasmania
city: Malvern
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Wodonga
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Melbourne
country: Australia
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Klagenfurt Am Woerthersee
country: Austria
facility: Novartis Investigative Site
city: Korneuburg
country: Austria
facility: Novartis Investigative Site
city: Krems
country: Austria
facility: Novartis Investigative Site
city: Leoben
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Oberpullendorf
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Bonheiden
country: Belgium
facility: Novartis Investigative Site
city: Duffel
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Kortrijk
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Libramont
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Namur
country: Belgium
facility: Novartis Investigative Site
city: Oostende
country: Belgium
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Jinan
country: China
facility: Novartis Investigative Site
state: Shandong
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Aalborg
country: Denmark
facility: Novartis Investigative Site
city: Herlev
country: Denmark
facility: Novartis Investigative Site
city: Herning
country: Denmark
facility: Novartis Investigative Site
city: Koebenhavn Oe
country: Denmark
facility: Novartis Investigative Site
city: ANGERS Cedex 2
country: France
facility: Novartis Investigative Site
city: Avignon cedex
country: France
facility: Novartis Investigative Site
city: Besancon Cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Bourg en Bresse Cedex
country: France
facility: Novartis Investigative Site
city: Brest Cedex
country: France
facility: Novartis Investigative Site
city: Brive La Gaillarde
country: France
facility: Novartis Investigative Site
city: Caen Cedex 05
country: France
facility: Novartis Investigative Site
city: Clermont-Ferrand cedex
country: France
facility: Novartis Investigative Site
city: Colmar Cedex
country: France
facility: Novartis Investigative Site
city: Dax Cedex
country: France
facility: Novartis Investigative Site
city: Grenoble Cedex 09
country: France
facility: Novartis Investigative Site
city: Grenoble Cedex
country: France
facility: Novartis Investigative Site
city: La Roche sur Yon Cedex 9
country: France
facility: Novartis Investigative Site
city: Le Chesnay Cedex
country: France
facility: Novartis Investigative Site
city: Le Mans
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Lorient cedex
country: France
facility: Novartis Investigative Site
city: Lyon Cedex 08
country: France
facility: Novartis Investigative Site
city: Marseille cedex
country: France
facility: Novartis Investigative Site
city: Metz Cedex 03
country: France
facility: Novartis Investigative Site
city: Mont de Marsan
country: France
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Mougins Cedex 2
country: France
facility: Novartis Investigative Site
city: Nancy
country: France
facility: Novartis Investigative Site
city: Nantes Cedex 2
country: France
facility: Novartis Investigative Site
city: Nice Cedex 2
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Orleans
country: France
facility: Novartis Investigative Site
city: Paris cedex 05
country: France
facility: Novartis Investigative Site
city: Paris Cedex 10
country: France
facility: Novartis Investigative Site
city: Paris Cedex 20
country: France
facility: Novartis Investigative Site
city: Paris Cedex 4
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Perigueux Cedex
country: France
facility: Novartis Investigative Site
city: Perin Sur Mer
country: France
facility: Novartis Investigative Site
city: Pierre-Benite Cedex
country: France
facility: Novartis Investigative Site
city: Reims Cedex
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint-Herblain
country: France
facility: Novartis Investigative Site
city: Saint-Priest en Jarez
country: France
facility: Novartis Investigative Site
city: Strasbourg Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Suresnes
country: France
facility: Novartis Investigative Site
city: Thonon-les-Bains
country: France
facility: Novartis Investigative Site
city: Vandoeuvre-Les-Nancy
country: France
facility: Novartis Investigative Site
city: Esslingen
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Freiburg
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Freiburg
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Mutlangen
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Reutlingen
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Schwaebisch Hall
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Coburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Deggendorf
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Ebersberg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Eggenfelden
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Fuerth
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Schweinfurt
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Darmstadt
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Fulda
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Kassel
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Lich
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Limburg
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Marburg
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Offenbach
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Offenbach
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Greifswald
country: Germany
facility: Novartis Investigative Site
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: Novartis Investigative Site
state: Mecklenburg-Vorpommern
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Cuxhaven
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Georgsmarienhuette
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Gifhorn
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Goettingen
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Goslar
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Leer
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Lueneburg
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Salzgitter
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Detmold
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Troisdorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Viersen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Quedlinburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Salzwedel
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Dresden
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Dresden
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Leipzg
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Radebeul
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Zwickau
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Flensburg
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Gera
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Nordhausen
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Suhl
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Kowloon
country: Hong Kong
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Waterford
country: Ireland
facility: Novartis Investigative Site
city: Wilton, Cork
country: Ireland
facility: Novartis Investigative Site
city: Potenza
country: Italy
facility: Novartis Investigative Site
state: Basilicata
city: Avellino
country: Italy
facility: Novartis Investigative Site
state: Campania
city: Napoli
country: Italy
facility: Novartis Investigative Site
state: Campania
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Carpi (MO)
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Faenza (RA)
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Aviano (PN)
country: Italy
facility: Novartis Investigative Site
state: Friuli-Venezia-Giulia
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Como
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Milano
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Milano
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Milano
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Milano
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Milano
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Monza
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Sondrio
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Varese
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Campobasso
country: Italy
facility: Novartis Investigative Site
state: Molise
city: Torino
country: Italy
facility: Novartis Investigative Site
state: Piemonte
city: Torino
country: Italy
facility: Novartis Investigative Site
state: Piemonte
city: Bari
country: Italy
facility: Novartis Investigative Site
state: Puglia
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: Sicilia
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: Umbria
city: Vicenza
country: Italy
facility: Novartis Investigative Site
state: Veneto
city: Ehime
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hokkaido
country: Japan
facility: Novartis Investigative Site
city: Iwate
country: Japan
facility: Novartis Investigative Site
city: Kagoshima
country: Japan
facility: Novartis Investigative Site
city: Miyagi
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tottori
country: Japan
facility: Novartis Investigative Site
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Kangnam-Ku ,Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Bergen
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Stavanger
country: Norway
facility: Novartis Investigative Site
city: Tromso
country: Norway
facility: Novartis Investigative Site
city: Alcorcon (Madrid)
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Cartagena (Murcia)
country: Spain
facility: Novartis Investigative Site
city: Elche
country: Spain
facility: Novartis Investigative Site
city: Lerida
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Murcia (El Palmar)
country: Spain
facility: Novartis Investigative Site
city: Palma de Mallorca
country: Spain
facility: Novartis Investigative Site
city: Pamplona
country: Spain
facility: Novartis Investigative Site
city: Sabadell (Barcelona)
country: Spain
facility: Novartis Investigative Site
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
city: Terrassa
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Linkoping
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Vergote I, du Bois A, Floquet A, Rau J, Kim JW, Del Campo JM, Friedlander M, Pignata S, Fujiwara K, Colombo N, Mirza MR, Monk BJ, Tsibulak I, Calvert PM, Herzog TJ, Hanker LC, Meunier J, Lee JY, Bologna A, Carrasco-Alfonso MJ, Harter P. Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer. Gynecol Oncol. 2019 Nov;155(2):186-191. doi: 10.1016/j.ygyno.2019.08.024. Epub 2019 Sep 10.
citation: Friedlander M, Rau J, Lee CK, Meier W, Lesoin A, Kim JW, Poveda A, Buck M, Scambia G, Shimada M, Hilpert F, King MT, Debruyne P, Bologna A, Malander S, Monk BJ, Petru E, Calvert P, Herzog TJ, Barrett C, du Bois A. Quality of life in patients with advanced epithelial ovarian cancer (EOC) randomized to maintenance pazopanib or placebo after first-line chemotherapy in the AGO-OVAR 16 trial. Measuring what matters-patient-centered end points in trials of maintenance therapy. Ann Oncol. 2018 Mar 1;29(3):737-743. doi: 10.1093/annonc/mdx796.
citation: Pulford DJ, Harter P, Floquet A, Barrett C, Suh DH, Friedlander M, Arranz JA, Hasegawa K, Tada H, Vuylsteke P, Mirza MR, Donadello N, Scambia G, Johnson T, Cox C, Chan JK, Imhof M, Herzog TJ, Calvert P, Wimberger P, Berton-Rigaud D, Lim MC, Elser G, Xu CF, du Bois A. Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study. BMC Med Ethics. 2016 Oct 21;17(1):63. doi: 10.1186/s12910-016-0144-y.
citation: Kim JW, Mahner S, Wu LY, Shoji T, Kim BG, Zhu JQ, Takano T, Park SY, Kong BH, Wu Q, Wang KL, Ngan HY, Liu JH, Wei LH, Mitrica I, Zhang P, Crescenzo R, Wang Q, Cox CJ, Harter P, du Bois A. Pazopanib Maintenance Therapy in East Asian Women With Advanced Epithelial Ovarian Cancer: Results From AGO-OVAR16 and an East Asian Study. Int J Gynecol Cancer. 2018 Jan;28(1):2-10. doi: 10.1097/IGC.0000000000000602.
citation: Floquet A, Vergote I, Colombo N, Fiane B, Monk BJ, Reinthaller A, Calvert P, Herzog TJ, Meier W, Kim JW, del Campo JM, Friedlander M, Pisano C, Isonishi S, Crescenzo RJ, Barrett C, Wang K, Mitrica I, du Bois A. Progression-free survival by local investigator versus independent central review: comparative analysis of the AGO-OVAR16 Trial. Gynecol Oncol. 2015 Jan;136(1):37-42. doi: 10.1016/j.ygyno.2014.11.074. Epub 2014 Nov 28.
citation: du Bois A, Floquet A, Kim JW, Rau J, del Campo JM, Friedlander M, Pignata S, Fujiwara K, Vergote I, Colombo N, Mirza MR, Monk BJ, Kimmig R, Ray-Coquard I, Zang R, Diaz-Padilla I, Baumann KH, Mouret-Reynier MA, Kim JH, Kurzeder C, Lesoin A, Vasey P, Marth C, Canzler U, Scambia G, Shimada M, Calvert P, Pujade-Lauraine E, Kim BG, Herzog TJ, Mitrica I, Schade-Brittinger C, Wang Q, Crescenzo R, Harter P. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol. 2014 Oct 20;32(30):3374-82. doi: 10.1200/JCO.2014.55.7348. Epub 2014 Sep 15.