AzTrials
AzTrials

Ovarian CancerPhase 3NCT00866697

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

A Phase 3 study testing Pazopanib in people with Ovarian Cancer, run by Novartis Pharmaceuticals at 318 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
940 participants
Where
318 sitesin 17 countries
Study dates
26 May 2009to 24 Aug 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

318 sites in 17 countries.

318 sites in 17 countries

Germany90 sites

  • Novartis Investigative Site

    Bayreuth, Bavaria, 95445

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 12683

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 13589

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 053123

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53111

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53113

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53127

  • Novartis Investigative Site

    Braunschweig, Lower Saxony, 38100

  • Novartis Investigative Site

    Chemnitz, Saxony, 09116

  • Novartis Investigative Site

    Coburg, Bavaria, 96450

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Cuxhaven, Lower Saxony, 27474

  • Novartis Investigative Site

    Darmstadt, Hesse, 64283

  • Novartis Investigative Site

    Deggendorf, Bavaria, 94469

  • Novartis Investigative Site

    Detmold, North Rhine-Westphalia, 32756

  • Novartis Investigative Site

    Dortmund, North Rhine-Westphalia, 44137

  • Novartis Investigative Site

    Dresden, Saxony, 01127

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Novartis Investigative Site

    Ebersberg, Bavaria, 85560

  • Novartis Investigative Site

    Eggenfelden, Bavaria, 84307

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45122

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45136

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45147

  • Novartis Investigative Site

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Novartis Investigative Site

    Flensburg, Schleswig-Holstein, 24939

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 65929

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79098

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Fulda, Hesse, 36043

  • Novartis Investigative Site

    Fürth, Bavaria, 90766

  • Novartis Investigative Site

    Georgsmarienhütte, Lower Saxony, 49124

  • Novartis Investigative Site

    Gera, Thuringia, 07548

  • Novartis Investigative Site

    Gifhorn, Lower Saxony, 38518

  • Novartis Investigative Site

    Goslar, Lower Saxony, 38642

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075

  • Novartis Investigative Site

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120

  • Novartis Investigative Site

    Hamburg, 20095

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hamburg, 22087

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30169

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30177

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30625

  • Novartis Investigative Site

    Hansestadt Salzwedel, Saxony-Anhalt, 29410

  • Novartis Investigative Site

    Hildesheim, Lower Saxony, 31134

  • Novartis Investigative Site

    Karlsruhe, Baden-Wurttemberg, 76133

  • Novartis Investigative Site

    Karlsruhe, Baden-Wurttemberg, 76135

  • Novartis Investigative Site

    Kassel, Hesse, 34125

  • Novartis Investigative Site

    Kiel, Schleswig-Holstein, 24105

  • Novartis Investigative Site

    Leer, Lower Saxony, 26789

  • Novartis Investigative Site

    Leipzg, Saxony, 04109

  • Novartis Investigative Site

    Lich, Hesse, 35423

  • Novartis Investigative Site

    Limburg an der Lahn, Hesse, 65549

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23538

  • Novartis Investigative Site

    Lüneburg, Lower Saxony, 21339

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39108

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39110

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55131

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68167

  • Novartis Investigative Site

    Marburg, Hesse, 35043

  • Novartis Investigative Site

    Munich, Bavaria, 80637

  • Novartis Investigative Site

    Munich, Bavaria, 81377

  • Novartis Investigative Site

    Munich, Bavaria, 81675

  • Novartis Investigative Site

    Mutlangen, Baden-Wurttemberg, 73557

  • Novartis Investigative Site

    Neuss, North Rhine-Westphalia, 41464

  • Novartis Investigative Site

    Nordhausen, Thuringia, 99734

  • Novartis Investigative Site

    Offenbach, Hesse, 63065

  • Novartis Investigative Site

    Offenbach, Hesse, 63069

  • Novartis Investigative Site

    Oldenburg, Lower Saxony, 26121

  • Novartis Investigative Site

    Quedlinburg, Saxony-Anhalt, 06484

  • Novartis Investigative Site

    Radebeul, Saxony, 01445

  • Novartis Investigative Site

    Reutlingen, Baden-Wurttemberg, 72764

  • Novartis Investigative Site

    Rostock, Mecklenburg-Vorpommern, 18059

  • Novartis Investigative Site

    Salzgitter, Lower Saxony, 38226

  • Novartis Investigative Site

    Schwäbisch Hall, Baden-Wurttemberg, 74523

  • Novartis Investigative Site

    Schweinfurt, Bavaria, 97422

  • Novartis Investigative Site

    Suhl, Thuringia, 98527

  • Novartis Investigative Site

    Trier, Rhineland-Palatinate, 54290

  • Novartis Investigative Site

    Troisdorf, North Rhine-Westphalia, 53840

  • Novartis Investigative Site

    Tübingen, Baden-Wurttemberg, 72076

  • Novartis Investigative Site

    Ulm, Baden-Wurttemberg, 89075

  • Novartis Investigative Site

    Viersen, North Rhine-Westphalia, 41747

  • Novartis Investigative Site

    Wiesbaden, Hesse, 65189

  • Novartis Investigative Site

    Wiesbaden, Hesse, 65199

  • Novartis Investigative Site

    Wolfsburg, Lower Saxony, 38440

  • Novartis Investigative Site

    Zwickau, Saxony, 08060

Other trials in Germany

France51 sites

  • Novartis Investigative Site

    Angers, 49055

  • Novartis Investigative Site

    Avignon, 84902

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Bordeaux, 33000

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Bordeaux, 33300

  • Novartis Investigative Site

    Bourg-en-Bresse, 01012

  • Novartis Investigative Site

    Brest, 29609

  • Novartis Investigative Site

    Brive-la-Gaillarde, 19100

  • Novartis Investigative Site

    Caen, 14076

  • Novartis Investigative Site

    Clermont-Ferrand, 63011

  • Novartis Investigative Site

    Colmar, 68024

  • Novartis Investigative Site

    Dax, 40107

  • Novartis Investigative Site

    Grenoble, 38028

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    La Roche-sur-Yon, 85925

  • Novartis Investigative Site

    Le Chesnay, 78157

  • Novartis Investigative Site

    Le Mans, 72015

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Lorient, 56322

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Marseille, 13008

  • Novartis Investigative Site

    Metz, 57085

  • Novartis Investigative Site

    Mont-de-Marsan, 40024

  • Novartis Investigative Site

    Montpellier, 34070

  • Novartis Investigative Site

    Montpellier, 34298

  • Novartis Investigative Site

    Mougins, 06250

  • Novartis Investigative Site

    Nancy, 54100

  • Novartis Investigative Site

    Nantes, 44277

  • Novartis Investigative Site

    Nice, 06189

  • Novartis Investigative Site

    Nîmes, 30907

  • Novartis Investigative Site

    Orléans, 45100

  • Novartis Investigative Site

    Paris, 75012

  • Novartis Investigative Site

    Paris, 75014

  • Novartis Investigative Site

    Paris, 75181

  • Novartis Investigative Site

    Paris, 75248

  • Novartis Investigative Site

    Paris, 75475

  • Novartis Investigative Site

    Paris, 75970

  • Novartis Investigative Site

    Périgueux, 24004

  • Novartis Investigative Site

    Perin Sur Mer, 22190

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Reims, 51056

  • Novartis Investigative Site

    Rouen, 76000

  • Novartis Investigative Site

    Saint-Herblain, 44805

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42271

  • Novartis Investigative Site

    Strasbourg, 67000

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Suresnes, 92151

  • Novartis Investigative Site

    Thonon-les-Bains, 74203

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

United States35 sites

  • Novartis Investigative Site

    Anaheim, California, 92807

  • Novartis Investigative Site

    Annandale, Virginia, 22003

  • Novartis Investigative Site

    Augusta, Georgia, 30912

  • Novartis Investigative Site

    Baldwin Park, California, 91706

  • Novartis Investigative Site

    Bellflower, California, 90706

  • Novartis Investigative Site

    Duarte, California, 91010

  • Novartis Investigative Site

    Fontana, California, 92335

  • Novartis Investigative Site

    Hayward, California, 94545

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Irvine, California, 92618

  • Novartis Investigative Site

    Long Beach, California, 90806

  • Novartis Investigative Site

    Los Angeles, California, 90027

  • Novartis Investigative Site

    Los Angeles, California, 90034

  • Novartis Investigative Site

    Los Angeles, California, 90095

  • Novartis Investigative Site

    Morristown, New Jersey, 07962-1956

  • Novartis Investigative Site

    New York, New York, 10032

  • Novartis Investigative Site

    New York, New York, 10065

  • Novartis Investigative Site

    Oakland, California, 94611

  • Novartis Investigative Site

    Ontario, California, 91761

  • Novartis Investigative Site

    Orange, California, 92868

  • Novartis Investigative Site

    Panorama City, California, 91402

  • Novartis Investigative Site

    Riverside, California, 92505

  • Novartis Investigative Site

    Roseville, California, 95661

  • Novartis Investigative Site

    Sacramento, California, 95817

  • Novartis Investigative Site

    Sacramento, California, 95825

  • Novartis Investigative Site

    San Diego, California, 92108

  • Novartis Investigative Site

    San Diego, California, 92120

  • Novartis Investigative Site

    San Francisco, California, 94115

  • Novartis Investigative Site

    San Jose, California, 95119-1110

  • Novartis Investigative Site

    Santa Clara, California, 95051

  • Novartis Investigative Site

    South San Francisco, California, 94080

  • Novartis Investigative Site

    The Bronx, New York, 10461

  • Novartis Investigative Site

    Vallejo, California, 94589

  • Novartis Investigative Site

    Walnut Creek, California, 94596

  • Novartis Investigative Site

    Woodland Hills, California, 91367

Other trials in United States

Italy29 sites

  • Novartis Investigative Site

    Avellino, Campania, 83100

  • Novartis Investigative Site

    Aviano (PN), Friuli Venezia Giulia, 33081

  • Novartis Investigative Site

    Bari, Apulia, 70124

  • Novartis Investigative Site

    Bologna, Emilia-Romagna, 40138

  • Novartis Investigative Site

    Bologna, Emilia-Romagna, 40139

  • Novartis Investigative Site

    Brescia, Lombardy

  • Novartis Investigative Site

    Campobasso, Molise, 86100

  • Novartis Investigative Site

    Carpi (MO), Emilia-Romagna, 41012

  • Novartis Investigative Site

    Como, Lombardy, 22100

  • Novartis Investigative Site

    Faenza (RA), Emilia-Romagna, 48018

  • Novartis Investigative Site

    Milan, Lombardy, 20122

  • Novartis Investigative Site

    Milan, Lombardy, 20132

  • Novartis Investigative Site

    Milan, Lombardy, 20133

  • Novartis Investigative Site

    Milan, Lombardy, 20141

  • Novartis Investigative Site

    Milan, Lombardy, 20162

  • Novartis Investigative Site

    Monza, Lombardy, 20052

  • Novartis Investigative Site

    Naples, Campania, 80131

  • Novartis Investigative Site

    Palermo, Sicily, 90146

  • Novartis Investigative Site

    Perugia, Umbria, 06132

  • Novartis Investigative Site

    Potenza, Basilicate, 85100

  • Novartis Investigative Site

    Reggio Emilia, Emilia-Romagna, 42100

  • Novartis Investigative Site

    Rome, Lazio, 00144

  • Novartis Investigative Site

    Rome, Lazio, 00168

  • Novartis Investigative Site

    Rome, Lazio, 00186

  • Novartis Investigative Site

    Sondrio, Lombardy, 23100

  • Novartis Investigative Site

    Turin, Piedmont, 10126

  • Novartis Investigative Site

    Turin, Piedmont, 10128

  • Novartis Investigative Site

    Varese, Lombardy, 21100

  • Novartis Investigative Site

    Vicenza, Veneto, 36100

Other trials in Italy

Spain23 sites

  • Novartis Investigative Site

    Alcorcon (Madrid), 28922

  • Novartis Investigative Site

    Barcelona, 080018

  • Novartis Investigative Site

    Barcelona, 08003

  • Novartis Investigative Site

    Barcelona, 08025

  • Novartis Investigative Site

    Barcelona, 08907

  • Novartis Investigative Site

    Cartagena (Murcia), 30203

  • Novartis Investigative Site

    Donostia / San Sebastian, 20014

  • Novartis Investigative Site

    Elche, 03203

  • Novartis Investigative Site

    Lleida, 25198

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28033

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Madrid, 28050

  • Novartis Investigative Site

    Murcia (El Palmar), 30120

  • Novartis Investigative Site

    Palma de Mallorca, 07198

  • Novartis Investigative Site

    Pamplona, 31008

  • Novartis Investigative Site

    Sabadell (Barcelona), 08208

  • Novartis Investigative Site

    Santiago de Compostela, 15706

  • Novartis Investigative Site

    Terrassa, 08227

  • Novartis Investigative Site

    Valencia, 46009

  • Novartis Investigative Site

    Valencia, 46014

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

Japan15 sites

  • Novartis Investigative Site

    Ehime, 791-0280

  • Novartis Investigative Site

    Fukuoka, 811-1395

  • Novartis Investigative Site

    Hiroshima, 734-8551

  • Novartis Investigative Site

    Hiroshima, 737-0023

  • Novartis Investigative Site

    Hokkaido, 060-8648

  • Novartis Investigative Site

    Kagoshima, 890-8760

  • Novartis Investigative Site

    Miyagi, 980-8574

  • Novartis Investigative Site

    Numakunai, 020-8505

  • Novartis Investigative Site

    Osaka, 589-8511

  • Novartis Investigative Site

    Saitama, 350-1298

  • Novartis Investigative Site

    Tokyo, 104-0045

  • Novartis Investigative Site

    Tokyo, 105-8471

  • Novartis Investigative Site

    Tokyo, 125-8506

  • Novartis Investigative Site

    Tokyo, 160-8582

  • Novartis Investigative Site

    Tottori, 683-8504

Other trials in Japan

Australia13 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050

  • Novartis Investigative Site

    Herston, Queensland, 4029

  • Novartis Investigative Site

    Hobart, Tasmania, 7000

  • Novartis Investigative Site

    Liverpool, New South Wales, 2170

  • Novartis Investigative Site

    Malvern, Victoria, 3144

  • Novartis Investigative Site

    Melbourne, 3084

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

  • Novartis Investigative Site

    Parkville, Victoria, 3052

  • Novartis Investigative Site

    Randwick, New South Wales, 2031

  • Novartis Investigative Site

    South Brisbane, Queensland, 4101

  • Novartis Investigative Site

    Waratah, New South Wales, 2298

  • Novartis Investigative Site

    Wodonga, Victoria, 3690

Other trials in Australia

Austria13 sites

  • Novartis Investigative Site

    Graz, 8020

  • Novartis Investigative Site

    Graz, A-8036

  • Novartis Investigative Site

    Innsbruck, 6020

  • Novartis Investigative Site

    Klagenfurt, 9020

  • Novartis Investigative Site

    Korneuburg, 2100

  • Novartis Investigative Site

    Krems, 3500

  • Novartis Investigative Site

    Leoben, 8700

  • Novartis Investigative Site

    Linz, 4010

  • Novartis Investigative Site

    Linz, 4020

  • Novartis Investigative Site

    Oberpullendorf, 7350

  • Novartis Investigative Site

    Vienna, 1090

  • Novartis Investigative Site

    Vienna, 1130

  • Novartis Investigative Site

    Vienna, 1160

Other trials in Austria

China13 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100044

  • Novartis Investigative Site

    Beijing, 100141

  • Novartis Investigative Site

    Beijing, 100853

  • Novartis Investigative Site

    Guangzhou, Guangdong

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022

  • Novartis Investigative Site

    Jinan, Shandong, 250012

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009

  • Novartis Investigative Site

    Shanghai, 200011

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Shenyang, Liaoning, 110022

  • Novartis Investigative Site

    Tianjin, 300060

Other trials in China

Belgium9 sites

  • Novartis Investigative Site

    Bonheiden, 2820

  • Novartis Investigative Site

    Duffel, 2570

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Libramont, 6800

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Namur, 5000

  • Novartis Investigative Site

    Ostend, 8400

Other trials in Belgium

Ireland6 sites

  • Novartis Investigative Site

    Dublin, 4

  • Novartis Investigative Site

    Dublin, 7

  • Novartis Investigative Site

    Dublin, 8

  • Novartis Investigative Site

    Dublin, 9

  • Novartis Investigative Site

    Waterford

  • Novartis Investigative Site

    Wilton, Cork

Other trials in Ireland

South Korea5 sites

  • Novartis Investigative Site

    Goyang-si, Gyeonggi-do, 410-769

  • Novartis Investigative Site

    Kangnam-Ku ,Seoul, (135-702)

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 135-710

  • Novartis Investigative Site

    Seoul, 138-736

Other trials in South Korea

Denmark4 sites

  • Novartis Investigative Site

    Aalborg, 9100

  • Novartis Investigative Site

    Herlev, DK-2730

  • Novartis Investigative Site

    Herning, 7400

  • Novartis Investigative Site

    Koebenhavn Oe, 2100

Other trials in Denmark

Norway4 sites

  • Novartis Investigative Site

    Bergen, 5021

  • Novartis Investigative Site

    Oslo, 0310

  • Novartis Investigative Site

    Stavanger, 4011

  • Novartis Investigative Site

    Tromsø, 9038

Other trials in Norway

Sweden4 sites

  • Novartis Investigative Site

    Linköping, SE-581 85

  • Novartis Investigative Site

    Lund, SE-221 85

  • Novartis Investigative Site

    Stockholm, SE-171 76

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

Hong Kong2 sites

  • Novartis Investigative Site

    Hong Kong

  • Novartis Investigative Site

    Kowloon

Other trials in Hong Kong

Taiwan2 sites

  • Novartis Investigative Site

    Taipei, 104

  • Novartis Investigative Site

    Taipei, 112

Other trials in Taiwan

About this study

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

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
Pazopanib, Placebo
Keywords
fallopian tube cancer, pazopanib, anti-angiogenesis, ovarian cancer, primary peritoneal cancer, tyrosine kinase inhibitors, gynecologic cancer
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Pazopanib 800 mg tablet daily for 104 weeks (24 months)

  • PlaceboDrug

    Matching placebo 800 mg tablet daily, for 104 weeks (24 months).

Study groups in NCT00866697
Study groupRoleWhat they receive
PlaceboPlacebo comparatormatched placebo tablet administered orally once daily for up to 24 months
Receives: Drug: Placebo
PazopanibExperimentalPazopanib tablet administered orally at 800 mg once daily for up to 24 months
Receives: Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: From the date of randomization until the date of death due to any cause up to approximately 25 months

  2. 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.

    Measured: From the date of randomization until the date of death due to any cause up to approximately 25 months

  3. 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.

    Measured: 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)

  4. 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.

    Measured: Up to 3 years after randomization

  5. 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).

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  6. 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.

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  7. 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.

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  8. 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.

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  9. 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.

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  10. 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.

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  11. 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).

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  12. 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).

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  13. 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.

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  14. 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.

    Measured: Baseline; Week 13; Months 7, 10, 13, 16, and 25

  15. 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.

    Measured: 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)

  16. 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.

    Measured: 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)

  17. 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.

    Measured: 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)

  18. 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 <TSH <=10 MU/L and T4 <lower limit of normal (LLN).

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2009 (estimated)
  2. Study start26 May 2009
  3. Primary completion8 Jul 2012
  4. Study completion24 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
940 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00866697
Sponsor's protocol ID
110655
Other IDs
2008-004672-50, CPZP034C2301, 2008
Status last verified
Jan 2021
First submitted
19 Mar 2009
Last updated
16 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • 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.

    PubMed 37185961

  • 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.

    PubMed 31519320

  • 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.

    PubMed 29267856

  • 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.

    PubMed 27769273

  • 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.

    PubMed 26588236

  • 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.

    PubMed 25434635

  • 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.

    PubMed 25225436

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pazopanib in people with Ovarian Cancer, run by Novartis Pharmaceuticals at 318 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 318 sites in Germany, France, United States, Italy, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-assessed Progression-free Survival (PFS) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00866697, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.

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