Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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
3 other identifiers
interventional
940
16 countries
305
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 ovarian-cancer
Started May 2009
Longer than P75 for phase_3 ovarian-cancer
305 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2009
CompletedFirst Posted
Study publicly available on registry
March 20, 2009
CompletedStudy Start
First participant enrolled
May 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2012
CompletedResults Posted
Study results publicly available
December 19, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2017
CompletedFebruary 16, 2021
January 1, 2021
3.1 years
March 19, 2009
July 3, 2013
January 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Overall Survival - Median
From the date of randomization until the date of death due to any cause up to approximately 25 months
Overall Survival: Number of Participants Experiencing Death
From the date of randomization until the date of death due to any cause up to approximately 25 months
Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria
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)
3-year Progression-free Survival
Up to 3 years after randomization
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
Baseline; Week 13; Months 7, 10, 13, 16, and 25
- +13 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORmatched placebo tablet administered orally once daily for up to 24 months
Pazopanib
EXPERIMENTALPazopanib tablet administered orally at 800 mg once daily for up to 24 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- GlaxoSmithKlinecollaborator
Study Sites (318)
Novartis Investigative Site
Anaheim, California, 92807, United States
Novartis Investigative Site
Baldwin Park, California, 91706, United States
Novartis Investigative Site
Bellflower, California, 90706, United States
Novartis Investigative Site
Duarte, California, 91010, United States
Novartis Investigative Site
Fontana, California, 92335, United States
Novartis Investigative Site
Hayward, California, 94545, United States
Novartis Investigative Site
Irvine, California, 92618, United States
Novartis Investigative Site
Long Beach, California, 90806, United States
Novartis Investigative Site
Los Angeles, California, 90027, United States
Novartis Investigative Site
Los Angeles, California, 90034, United States
Novartis Investigative Site
Los Angeles, California, 90095, United States
Novartis Investigative Site
Oakland, California, 94611, United States
Novartis Investigative Site
Ontario, California, 91761, United States
Novartis Investigative Site
Orange, California, 92868, United States
Novartis Investigative Site
Panorama City, California, 91402, United States
Novartis Investigative Site
Riverside, California, 92505, United States
Novartis Investigative Site
Roseville, California, 95661, United States
Novartis Investigative Site
Sacramento, California, 95817, United States
Novartis Investigative Site
Sacramento, California, 95825, United States
Novartis Investigative Site
San Diego, California, 92108, United States
Novartis Investigative Site
San Diego, California, 92120, United States
Novartis Investigative Site
San Francisco, California, 94115, United States
Novartis Investigative Site
San Jose, California, 95119-1110, United States
Novartis Investigative Site
Santa Clara, California, 95051, United States
Novartis Investigative Site
South San Francisco, California, 94080, United States
Novartis Investigative Site
Vallejo, California, 94589, United States
Novartis Investigative Site
Walnut Creek, California, 94596, United States
Novartis Investigative Site
Woodland Hills, California, 91367, United States
Novartis Investigative Site
Augusta, Georgia, 30912, United States
Novartis Investigative Site
Morristown, New Jersey, 07962-1956, United States
Novartis Investigative Site
New York, New York, 10032, United States
Novartis Investigative Site
New York, New York, 10065, United States
Novartis Investigative Site
The Bronx, New York, 10461, United States
Novartis Investigative Site
Houston, Texas, 77030, United States
Novartis Investigative Site
Annandale, Virginia, 22003, United States
Novartis Investigative Site
Camperdown, New South Wales, 2050, Australia
Novartis Investigative Site
Liverpool, New South Wales, 2170, Australia
Novartis Investigative Site
Randwick, New South Wales, 2031, Australia
Novartis Investigative Site
Waratah, New South Wales, 2298, Australia
Novartis Investigative Site
Herston, Queensland, 4029, Australia
Novartis Investigative Site
South Brisbane, Queensland, 4101, Australia
Novartis Investigative Site
Adelaide, South Australia, 5000, Australia
Novartis Investigative Site
Hobart, Tasmania, 7000, Australia
Novartis Investigative Site
Malvern, Victoria, 3144, Australia
Novartis Investigative Site
Parkville, Victoria, 3052, Australia
Novartis Investigative Site
Wodonga, Victoria, 3690, Australia
Novartis Investigative Site
Nedlands, Western Australia, 6009, Australia
Novartis Investigative Site
Melbourne, 3084, Australia
Novartis Investigative Site
Graz, 8020, Austria
Novartis Investigative Site
Graz, A-8036, Austria
Novartis Investigative Site
Innsbruck, 6020, Austria
Novartis Investigative Site
Klagenfurt, 9020, Austria
Novartis Investigative Site
Korneuburg, 2100, Austria
Novartis Investigative Site
Krems, 3500, Austria
Novartis Investigative Site
Leoben, 8700, Austria
Novartis Investigative Site
Linz, 4010, Austria
Novartis Investigative Site
Linz, 4020, Austria
Novartis Investigative Site
Oberpullendorf, 7350, Austria
Novartis Investigative Site
Vienna, 1090, Austria
Novartis Investigative Site
Vienna, 1130, Austria
Novartis Investigative Site
Vienna, 1160, Austria
Novartis Investigative Site
Bonheiden, 2820, Belgium
Novartis Investigative Site
Duffel, 2570, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Kortrijk, 8500, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Libramont, 6800, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Namur, 5000, Belgium
Novartis Investigative Site
Ostend, 8400, Belgium
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Nanjing, Jiangsu, 210009, China
Novartis Investigative Site
Shenyang, Liaoning, 110022, China
Novartis Investigative Site
Jinan, Shandong, 250012, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310006, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310022, China
Novartis Investigative Site
Beijing, 100021, China
Novartis Investigative Site
Beijing, 100044, China
Novartis Investigative Site
Beijing, 100141, China
Novartis Investigative Site
Beijing, 100853, China
Novartis Investigative Site
Shanghai, 200011, China
Novartis Investigative Site
Shanghai, 200032, China
Novartis Investigative Site
Tianjin, 300060, China
Novartis Investigative Site
Aalborg, 9100, Denmark
Novartis Investigative Site
Herlev, DK-2730, Denmark
Novartis Investigative Site
Herning, 7400, Denmark
Novartis Investigative Site
Koebenhavn Oe, 2100, Denmark
Novartis Investigative Site
Angers, 49055, France
Novartis Investigative Site
Avignon, 84902, France
Novartis Investigative Site
Besançon, 25030, France
Novartis Investigative Site
Bordeaux, 33000, France
Novartis Investigative Site
Bordeaux, 33076, France
Novartis Investigative Site
Bordeaux, 33300, France
Novartis Investigative Site
Bourg-en-Bresse, 01012, France
Novartis Investigative Site
Brest, 29609, France
Novartis Investigative Site
Brive-la-Gaillarde, 19100, France
Novartis Investigative Site
Caen, 14076, France
Novartis Investigative Site
Clermont-Ferrand, 63011, France
Novartis Investigative Site
Colmar, 68024, France
Novartis Investigative Site
Dax, 40107, France
Novartis Investigative Site
Grenoble, 38028, France
Novartis Investigative Site
Grenoble, 38043, France
Novartis Investigative Site
La Roche-sur-Yon, 85925, France
Novartis Investigative Site
Le Chesnay, 78157, France
Novartis Investigative Site
Le Mans, 72015, France
Novartis Investigative Site
Lille, 59020, France
Novartis Investigative Site
Lille, 59037, France
Novartis Investigative Site
Lorient, 56322, France
Novartis Investigative Site
Lyon, 69373, France
Novartis Investigative Site
Marseille, 13008, France
Novartis Investigative Site
Metz, 57085, France
Novartis Investigative Site
Mont-de-Marsan, 40024, France
Novartis Investigative Site
Montpellier, 34070, France
Novartis Investigative Site
Montpellier, 34298, France
Novartis Investigative Site
Mougins, 06250, France
Novartis Investigative Site
Nancy, 54100, France
Novartis Investigative Site
Nantes, 44277, France
Novartis Investigative Site
Nice, 06189, France
Novartis Investigative Site
Nîmes, 30907, France
Novartis Investigative Site
Orléans, 45100, France
Novartis Investigative Site
Paris, 75012, France
Novartis Investigative Site
Paris, 75014, France
Novartis Investigative Site
Paris, 75181, France
Novartis Investigative Site
Paris, 75248, France
Novartis Investigative Site
Paris, 75475, France
Novartis Investigative Site
Paris, 75970, France
Novartis Investigative Site
Perin Sur Mer, 22190, France
Novartis Investigative Site
Périgueux, 24004, France
Novartis Investigative Site
Pierre-Bénite, 69495, France
Novartis Investigative Site
Reims, 51056, France
Novartis Investigative Site
Rouen, 76000, France
Novartis Investigative Site
Saint-Herblain, 44805, France
Novartis Investigative Site
Saint-Priest-en-Jarez, 42271, France
Novartis Investigative Site
Strasbourg, 67000, France
Novartis Investigative Site
Strasbourg, 67091, France
Novartis Investigative Site
Suresnes, 92151, France
Novartis Investigative Site
Thonon-les-Bains, 74203, France
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511, France
Novartis Investigative Site
Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79098, Germany
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Novartis Investigative Site
Karlsruhe, Baden-Wurttemberg, 76133, Germany
Novartis Investigative Site
Karlsruhe, Baden-Wurttemberg, 76135, Germany
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 68167, Germany
Novartis Investigative Site
Mutlangen, Baden-Wurttemberg, 73557, Germany
Novartis Investigative Site
Reutlingen, Baden-Wurttemberg, 72764, Germany
Novartis Investigative Site
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
Novartis Investigative Site
Tübingen, Baden-Wurttemberg, 72076, Germany
Novartis Investigative Site
Ulm, Baden-Wurttemberg, 89075, Germany
Novartis Investigative Site
Bayreuth, Bavaria, 95445, Germany
Novartis Investigative Site
Coburg, Bavaria, 96450, Germany
Novartis Investigative Site
Deggendorf, Bavaria, 94469, Germany
Novartis Investigative Site
Ebersberg, Bavaria, 85560, Germany
Novartis Investigative Site
Eggenfelden, Bavaria, 84307, Germany
Novartis Investigative Site
Fürth, Bavaria, 90766, Germany
Novartis Investigative Site
Munich, Bavaria, 80637, Germany
Novartis Investigative Site
Munich, Bavaria, 81377, Germany
Novartis Investigative Site
Munich, Bavaria, 81675, Germany
Novartis Investigative Site
Schweinfurt, Bavaria, 97422, Germany
Novartis Investigative Site
Darmstadt, Hesse, 64283, Germany
Novartis Investigative Site
Frankfurt am Main, Hesse, 60590, Germany
Novartis Investigative Site
Frankfurt am Main, Hesse, 65929, Germany
Novartis Investigative Site
Fulda, Hesse, 36043, Germany
Novartis Investigative Site
Kassel, Hesse, 34125, Germany
Novartis Investigative Site
Lich, Hesse, 35423, Germany
Novartis Investigative Site
Limburg an der Lahn, Hesse, 65549, Germany
Novartis Investigative Site
Marburg, Hesse, 35043, Germany
Novartis Investigative Site
Offenbach, Hesse, 63065, Germany
Novartis Investigative Site
Offenbach, Hesse, 63069, Germany
Novartis Investigative Site
Wiesbaden, Hesse, 65189, Germany
Novartis Investigative Site
Wiesbaden, Hesse, 65199, Germany
Novartis Investigative Site
Braunschweig, Lower Saxony, 38100, Germany
Novartis Investigative Site
Cuxhaven, Lower Saxony, 27474, Germany
Novartis Investigative Site
Georgsmarienhütte, Lower Saxony, 49124, Germany
Novartis Investigative Site
Gifhorn, Lower Saxony, 38518, Germany
Novartis Investigative Site
Goslar, Lower Saxony, 38642, Germany
Novartis Investigative Site
Göttingen, Lower Saxony, 37075, Germany
Novartis Investigative Site
Hanover, Lower Saxony, 30169, Germany
Novartis Investigative Site
Hanover, Lower Saxony, 30177, Germany
Novartis Investigative Site
Hanover, Lower Saxony, 30625, Germany
Novartis Investigative Site
Hildesheim, Lower Saxony, 31134, Germany
Novartis Investigative Site
Leer, Lower Saxony, 26789, Germany
Novartis Investigative Site
Lüneburg, Lower Saxony, 21339, Germany
Novartis Investigative Site
Oldenburg, Lower Saxony, 26121, Germany
Novartis Investigative Site
Salzgitter, Lower Saxony, 38226, Germany
Novartis Investigative Site
Wolfsburg, Lower Saxony, 38440, Germany
Novartis Investigative Site
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
Novartis Investigative Site
Rostock, Mecklenburg-Vorpommern, 18059, Germany
Novartis Investigative Site
Bonn, North Rhine-Westphalia, 053123, Germany
Novartis Investigative Site
Bonn, North Rhine-Westphalia, 53111, Germany
Novartis Investigative Site
Bonn, North Rhine-Westphalia, 53113, Germany
Novartis Investigative Site
Bonn, North Rhine-Westphalia, 53127, Germany
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937, Germany
Novartis Investigative Site
Detmold, North Rhine-Westphalia, 32756, Germany
Novartis Investigative Site
Dortmund, North Rhine-Westphalia, 44137, Germany
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45122, Germany
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45136, Germany
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45147, Germany
Novartis Investigative Site
Neuss, North Rhine-Westphalia, 41464, Germany
Novartis Investigative Site
Troisdorf, North Rhine-Westphalia, 53840, Germany
Novartis Investigative Site
Viersen, North Rhine-Westphalia, 41747, Germany
Novartis Investigative Site
Mainz, Rhineland-Palatinate, 55131, Germany
Novartis Investigative Site
Trier, Rhineland-Palatinate, 54290, Germany
Novartis Investigative Site
Chemnitz, Saxony, 09116, Germany
Novartis Investigative Site
Dresden, Saxony, 01127, Germany
Novartis Investigative Site
Dresden, Saxony, 01307, Germany
Novartis Investigative Site
Leipzg, Saxony, 04109, Germany
Novartis Investigative Site
Radebeul, Saxony, 01445, Germany
Novartis Investigative Site
Zwickau, Saxony, 08060, Germany
Novartis Investigative Site
Halle, Saxony-Anhalt, 06120, Germany
Novartis Investigative Site
Magdeburg, Saxony-Anhalt, 39108, Germany
Novartis Investigative Site
Magdeburg, Saxony-Anhalt, 39110, Germany
Novartis Investigative Site
Quedlinburg, Saxony-Anhalt, 06484, Germany
Novartis Investigative Site
Salzwedel, Saxony-Anhalt, 29410, Germany
Novartis Investigative Site
Flensburg, Schleswig-Holstein, 24939, Germany
Novartis Investigative Site
Kiel, Schleswig-Holstein, 24105, Germany
Novartis Investigative Site
Lübeck, Schleswig-Holstein, 23538, Germany
Novartis Investigative Site
Gera, Thuringia, 07548, Germany
Novartis Investigative Site
Nordhausen, Thuringia, 99734, Germany
Novartis Investigative Site
Suhl, Thuringia, 98527, Germany
Novartis Investigative Site
Berlin, 10367, Germany
Novartis Investigative Site
Berlin, 12683, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Berlin, 13589, Germany
Novartis Investigative Site
Hamburg, 20095, Germany
Novartis Investigative Site
Hamburg, 20246, Germany
Novartis Investigative Site
Hamburg, 22087, Germany
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Kowloon, Hong Kong
Novartis Investigative Site
Dublin, 4, Ireland
Novartis Investigative Site
Dublin, 7, Ireland
Novartis Investigative Site
Dublin, 8, Ireland
Novartis Investigative Site
Dublin, 9, Ireland
Novartis Investigative Site
Waterford, Ireland
Novartis Investigative Site
Wilton, Cork, Ireland
Novartis Investigative Site
Bari, Apulia, 70124, Italy
Novartis Investigative Site
Potenza, Basilicate, 85100, Italy
Novartis Investigative Site
Avellino, Campania, 83100, Italy
Novartis Investigative Site
Napoli, Campania, 80131, Italy
Novartis Investigative Site
Bologna, Emilia-Romagna, 40138, Italy
Novartis Investigative Site
Bologna, Emilia-Romagna, 40139, Italy
Novartis Investigative Site
Carpi (MO), Emilia-Romagna, 41012, Italy
Novartis Investigative Site
Faenza (RA), Emilia-Romagna, 48018, Italy
Novartis Investigative Site
Reggio Emilia, Emilia-Romagna, 42100, Italy
Novartis Investigative Site
Aviano (PN), Friuli Venezia Giulia, 33081, Italy
Novartis Investigative Site
Rome, Lazio, 00144, Italy
Novartis Investigative Site
Rome, Lazio, 00168, Italy
Novartis Investigative Site
Rome, Lazio, 00186, Italy
Novartis Investigative Site
Brescia, Lombardy, Italy
Novartis Investigative Site
Como, Lombardy, 22100, Italy
Novartis Investigative Site
Milan, Lombardy, 20122, Italy
Novartis Investigative Site
Milan, Lombardy, 20132, Italy
Novartis Investigative Site
Milan, Lombardy, 20133, Italy
Novartis Investigative Site
Milan, Lombardy, 20141, Italy
Novartis Investigative Site
Milan, Lombardy, 20162, Italy
Novartis Investigative Site
Monza, Lombardy, 20052, Italy
Novartis Investigative Site
Sondrio, Lombardy, 23100, Italy
Novartis Investigative Site
Varese, Lombardy, 21100, Italy
Novartis Investigative Site
Campobasso, Molise, 86100, Italy
Novartis Investigative Site
Turin, Piedmont, 10126, Italy
Novartis Investigative Site
Turin, Piedmont, 10128, Italy
Novartis Investigative Site
Palermo, Sicily, 90146, Italy
Novartis Investigative Site
Perugia, Umbria, 06132, Italy
Novartis Investigative Site
Vicenza, Veneto, 36100, Italy
Novartis Investigative Site
Ehime, 791-0280, Japan
Novartis Investigative Site
Fukuoka, 811-1395, Japan
Novartis Investigative Site
Hiroshima, 734-8551, Japan
Novartis Investigative Site
Hiroshima, 737-0023, Japan
Novartis Investigative Site
Hokkaido, 060-8648, Japan
Novartis Investigative Site
Kagoshima, 890-8760, Japan
Novartis Investigative Site
Miyagi, 980-8574, Japan
Novartis Investigative Site
Numakunai, 020-8505, Japan
Novartis Investigative Site
Osaka, 589-8511, Japan
Novartis Investigative Site
Saitama, 350-1298, Japan
Novartis Investigative Site
Tokyo, 104-0045, Japan
Novartis Investigative Site
Tokyo, 105-8471, Japan
Novartis Investigative Site
Tokyo, 125-8506, Japan
Novartis Investigative Site
Tokyo, 160-8582, Japan
Novartis Investigative Site
Tottori, 683-8504, Japan
Novartis Investigative Site
Bergen, 5021, Norway
Novartis Investigative Site
Oslo, 0310, Norway
Novartis Investigative Site
Stavanger, 4011, Norway
Novartis Investigative Site
Tromsø, 9038, Norway
Novartis Investigative Site
Goyang-si, Gyeonggi-do, 410-769, South Korea
Novartis Investigative Site
Kangnam-Ku ,Seoul, (135-702), South Korea
Novartis Investigative Site
Seoul, 03080, South Korea
Novartis Investigative Site
Seoul, 135-710, South Korea
Novartis Investigative Site
Seoul, 138-736, South Korea
Novartis Investigative Site
Alcorcon (Madrid), 28922, Spain
Novartis Investigative Site
Barcelona, 080018, Spain
Novartis Investigative Site
Barcelona, 08003, Spain
Novartis Investigative Site
Barcelona, 08025, Spain
Novartis Investigative Site
Barcelona, 08907, Spain
Novartis Investigative Site
Cartagena (Murcia), 30203, Spain
Novartis Investigative Site
Donostia / San Sebastian, 20014, Spain
Novartis Investigative Site
Elche, 03203, Spain
Novartis Investigative Site
Lleida, 25198, Spain
Novartis Investigative Site
Madrid, 28007, Spain
Novartis Investigative Site
Madrid, 28033, Spain
Novartis Investigative Site
Madrid, 28034, Spain
Novartis Investigative Site
Madrid, 28046, Spain
Novartis Investigative Site
Madrid, 28050, Spain
Novartis Investigative Site
Murcia (El Palmar), 30120, Spain
Novartis Investigative Site
Palma de Mallorca, 07198, Spain
Novartis Investigative Site
Pamplona, 31008, Spain
Novartis Investigative Site
Sabadell (Barcelona), 08208, Spain
Novartis Investigative Site
Santiago de Compostela, 15706, Spain
Novartis Investigative Site
Terrassa, 08227, Spain
Novartis Investigative Site
Valencia, 46009, Spain
Novartis Investigative Site
Valencia, 46014, Spain
Novartis Investigative Site
Zaragoza, 50009, Spain
Novartis Investigative Site
Linköping, SE-581 85, Sweden
Novartis Investigative Site
Lund, SE-221 85, Sweden
Novartis Investigative Site
Stockholm, SE-171 76, Sweden
Novartis Investigative Site
Uppsala, SE-751 85, Sweden
Novartis Investigative Site
Taipei, 104, Taiwan
Novartis Investigative Site
Taipei, 112, Taiwan
Related Publications (7)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVEDVergote 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.
PMID: 31519320DERIVEDFriedlander 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.
PMID: 29267856DERIVEDPulford 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.
PMID: 27769273DERIVEDKim 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.
PMID: 26588236DERIVEDFloquet 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.
PMID: 25434635DERIVEDdu 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.
PMID: 25225436DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Disclosure Office
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2009
First Posted
March 20, 2009
Study Start
May 26, 2009
Primary Completion
July 8, 2012
Study Completion
August 24, 2017
Last Updated
February 16, 2021
Results First Posted
December 19, 2013
Record last verified: 2021-01