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

2021年1月27日 更新者：Novartis Pharmaceuticals

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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

940

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アイルランド
      • Dublin、アイルランド、7
        • Novartis Investigative Site
      • Dublin、アイルランド、8
        • Novartis Investigative Site
      • Dublin、アイルランド、9
        • Novartis Investigative Site
      • Dublin、アイルランド、4
        • Novartis Investigative Site
      • Waterford、アイルランド
        • Novartis Investigative Site
      • Wilton, Cork、アイルランド
        • Novartis Investigative Site
  • アメリカ
    • California
      • Anaheim、California、アメリカ、92807
        • Novartis Investigative Site
      • Baldwin Park、California、アメリカ、91706
        • Novartis Investigative Site
      • Bellflower、California、アメリカ、90706
        • Novartis Investigative Site
      • Duarte、California、アメリカ、91010
        • Novartis Investigative Site
      • Fontana、California、アメリカ、92335
        • Novartis Investigative Site
      • Hayward、California、アメリカ、94545
        • Novartis Investigative Site
      • Irvine、California、アメリカ、92618
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      • Long Beach、California、アメリカ、90806
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      • Los Angeles、California、アメリカ、90027
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      • Los Angeles、California、アメリカ、90095
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      • Los Angeles、California、アメリカ、90034
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      • Oakland、California、アメリカ、94611
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      • Ontario、California、アメリカ、91761
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      • Orange、California、アメリカ、92868
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      • Panorama City、California、アメリカ、91402
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      • Riverside、California、アメリカ、92505
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      • Roseville、California、アメリカ、95661
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      • Sacramento、California、アメリカ、95817
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      • Sacramento、California、アメリカ、95825
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      • San Diego、California、アメリカ、92120
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      • San Diego、California、アメリカ、92108
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      • San Francisco、California、アメリカ、94115
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      • San Jose、California、アメリカ、95119-1110
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      • Vallejo、California、アメリカ、94589
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      • Woodland Hills、California、アメリカ、91367
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      • Augusta、Georgia、アメリカ、30912
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      • Morristown、New Jersey、アメリカ、07962-1956
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      • Bronx、New York、アメリカ、10461
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      • New York、New York、アメリカ、10032
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      • Annandale、Virginia、アメリカ、22003
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      • Potenza、Basilicata、イタリア、85100
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      • Aviano (PN)、Friuli-Venezia-Giulia、イタリア、33081
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      • Roma、Lazio、イタリア、00168
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      • Melbourne、オーストラリア、3084
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      • Herston、Queensland、オーストラリア、4029
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      • Nedlands、Western Australia、オーストラリア、6009
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      • Graz、オーストリア、A-8036
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      • Graz、オーストリア、8020
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      • Krems、オーストリア、3500
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      • Leoben、オーストリア、8700
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      • Linz、オーストリア、4020
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      • Linz、オーストリア、4010
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      • Oberpullendorf、オーストリア、7350
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      • Wien、オーストリア、1130
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      • Wien、オーストリア、1160
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  • スウェーデン
      • Linkoping、スウェーデン、SE-581 85
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      • Lund、スウェーデン、SE-221 85
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      • Stockholm、スウェーデン、SE-171 76
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      • Uppsala、スウェーデン、SE-751 85
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  • スペイン
      • Alcorcon (Madrid)、スペイン、28922
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      • Barcelona、スペイン、08025
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      • Barcelona、スペイン、08003
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      • Barcelona、スペイン、08907
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      • Barcelona、スペイン、080018
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      • Cartagena (Murcia)、スペイン、30203
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      • Elche、スペイン、03203
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      • Lerida、スペイン、25198
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      • Madrid、スペイン、28034
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      • Madrid、スペイン、28046
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      • Madrid、スペイン、28007
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      • Madrid、スペイン、28033
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      • Madrid、スペイン、28050
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      • Murcia (El Palmar)、スペイン、30120
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      • Palma de Mallorca、スペイン、07198
        • Novartis Investigative Site
      • Pamplona、スペイン、31008
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      • Sabadell (Barcelona)、スペイン、08208
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      • San Sebastian、スペイン、20014
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      • Santiago de Compostela、スペイン、15706
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      • Terrassa、スペイン、08227
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      • Valencia、スペイン、46014
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      • Valencia、スペイン、46009
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      • Zaragoza、スペイン、50009
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  • デンマーク
      • Aalborg、デンマーク、9100
        • Novartis Investigative Site
      • Herlev、デンマーク、DK-2730
        • Novartis Investigative Site
      • Herning、デンマーク、7400
        • Novartis Investigative Site
      • Koebenhavn Oe、デンマーク、2100
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  • ドイツ
      • Berlin、ドイツ、10367
        • Novartis Investigative Site
      • Berlin、ドイツ、13589
        • Novartis Investigative Site
      • Berlin、ドイツ、13353
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      • Berlin、ドイツ、12683
        • Novartis Investigative Site
      • Hamburg、ドイツ、20246
        • Novartis Investigative Site
      • Hamburg、ドイツ、20095
        • Novartis Investigative Site
      • Hamburg、ドイツ、22087
        • Novartis Investigative Site
    • Baden-Wuerttemberg
      • Esslingen、Baden-Wuerttemberg、ドイツ、73730
        • Novartis Investigative Site
      • Freiburg、Baden-Wuerttemberg、ドイツ、79106
        • Novartis Investigative Site
      • Freiburg、Baden-Wuerttemberg、ドイツ、79098
        • Novartis Investigative Site
      • Karlsruhe、Baden-Wuerttemberg、ドイツ、76133
        • Novartis Investigative Site
      • Karlsruhe、Baden-Wuerttemberg、ドイツ、76135
        • Novartis Investigative Site
      • Mannheim、Baden-Wuerttemberg、ドイツ、68167
        • Novartis Investigative Site
      • Mutlangen、Baden-Wuerttemberg、ドイツ、73557
        • Novartis Investigative Site
      • Reutlingen、Baden-Wuerttemberg、ドイツ、72764
        • Novartis Investigative Site
      • Schwaebisch Hall、Baden-Wuerttemberg、ドイツ、74523
        • Novartis Investigative Site
      • Tuebingen、Baden-Wuerttemberg、ドイツ、72076
        • Novartis Investigative Site
      • Ulm、Baden-Wuerttemberg、ドイツ、89075
        • Novartis Investigative Site
    • Bayern
      • Bayreuth、Bayern、ドイツ、95445
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      • Coburg、Bayern、ドイツ、96450
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      • Deggendorf、Bayern、ドイツ、94469
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      • Ebersberg、Bayern、ドイツ、85560
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      • Eggenfelden、Bayern、ドイツ、84307
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      • Fuerth、Bayern、ドイツ、90766
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      • Muenchen、Bayern、ドイツ、80637
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      • Muenchen、Bayern、ドイツ、81675
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      • Muenchen、Bayern、ドイツ、81377
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      • Schweinfurt、Bayern、ドイツ、97422
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    • Hessen
      • Darmstadt、Hessen、ドイツ、64283
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      • Frankfurt、Hessen、ドイツ、65929
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      • Frankfurt am Main、Hessen、ドイツ、60590
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      • Lich、Hessen、ドイツ、35423
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    • Mecklenburg-Vorpommern
      • Greifswald、Mecklenburg-Vorpommern、ドイツ、17475
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    • Niedersachsen
      • Braunschweig、Niedersachsen、ドイツ、38100
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    • Nordrhein-Westfalen
      • Bonn、Nordrhein-Westfalen、ドイツ、53127
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        • Novartis Investigative Site
      • Paris Cedex 4、フランス、75181
        • Novartis Investigative Site
      • Paris cedex 05、フランス、75248
        • Novartis Investigative Site
      • Perigueux Cedex、フランス、24004
        • Novartis Investigative Site
      • Perin Sur Mer、フランス、22190
        • Novartis Investigative Site
      • Pierre-Benite Cedex、フランス、69495
        • Novartis Investigative Site
      • Reims Cedex、フランス、51056
        • Novartis Investigative Site
      • Rouen、フランス、76000
        • Novartis Investigative Site
      • Saint-Herblain、フランス、44805
        • Novartis Investigative Site
      • Saint-Priest en Jarez、フランス、42271
        • Novartis Investigative Site
      • Strasbourg、フランス、67000
        • Novartis Investigative Site
      • Strasbourg Cedex、フランス、67091
        • Novartis Investigative Site
      • Suresnes、フランス、92151
        • Novartis Investigative Site
      • Thonon-les-Bains、フランス、74203
        • Novartis Investigative Site
      • Vandoeuvre-Les-Nancy、フランス、54511
        • Novartis Investigative Site
  • ベルギー
      • Bonheiden、ベルギー、2820
        • Novartis Investigative Site
      • Duffel、ベルギー、2570
        • Novartis Investigative Site
      • Gent、ベルギー、9000
        • Novartis Investigative Site
      • Kortrijk、ベルギー、8500
        • Novartis Investigative Site
      • Leuven、ベルギー、3000
        • Novartis Investigative Site
      • Libramont、ベルギー、6800
        • Novartis Investigative Site
      • Liege、ベルギー、4000
        • Novartis Investigative Site
      • Namur、ベルギー、5000
        • Novartis Investigative Site
      • Oostende、ベルギー、8400
        • Novartis Investigative Site
  • 中国
      • Beijing、中国、100044
        • Novartis Investigative Site
      • Beijing、中国、100021
        • Novartis Investigative Site
      • Beijing、中国、100853
        • Novartis Investigative Site
      • Beijing、中国、100141
        • Novartis Investigative Site
      • Shanghai、中国、200032
        • Novartis Investigative Site
      • Shanghai、中国、200011
        • Novartis Investigative Site
      • Tianjin、中国、300060
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou、Guangdong、中国
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing、Jiangsu、中国、210009
        • Novartis Investigative Site
    • Liaoning
      • Shenyang、Liaoning、中国、110022
        • Novartis Investigative Site
    • Shandong
      • Jinan、Shandong、中国、250012
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310006
        • Novartis Investigative Site
      • Hangzhou、Zhejiang、中国、310022
        • Novartis Investigative Site
  • 台湾
      • Taipei、台湾、104
        • Novartis Investigative Site
      • Taipei、台湾、112
        • Novartis Investigative Site
  • 大韓民国
      • Goyang-si, Gyeonggi-do、大韓民国、410-769
        • Novartis Investigative Site
      • Kangnam-Ku ,Seoul、大韓民国、(135-702)
        • Novartis Investigative Site
      • Seoul、大韓民国、03080
        • Novartis Investigative Site
      • Seoul、大韓民国、138-736
        • Novartis Investigative Site
      • Seoul、大韓民国、135-710
        • Novartis Investigative Site
  • 日本
      • Ehime、日本、791-0280
        • Novartis Investigative Site
      • Fukuoka、日本、811-1395
        • Novartis Investigative Site
      • Hiroshima、日本、734-8551
        • Novartis Investigative Site
      • Hiroshima、日本、737-0023
        • Novartis Investigative Site
      • Hokkaido、日本、060-8648
        • Novartis Investigative Site
      • Iwate、日本、020-8505
        • Novartis Investigative Site
      • Kagoshima、日本、890-8760
        • Novartis Investigative Site
      • Miyagi、日本、980-8574
        • Novartis Investigative Site
      • Osaka、日本、589-8511
        • Novartis Investigative Site
      • Saitama、日本、350-1298
        • Novartis Investigative Site
      • Tokyo、日本、104-0045
        • Novartis Investigative Site
      • Tokyo、日本、160-8582
        • Novartis Investigative Site
      • Tokyo、日本、105-8471
        • Novartis Investigative Site
      • Tokyo、日本、125-8506
        • Novartis Investigative Site
      • Tottori、日本、683-8504
        • Novartis Investigative Site
  • 香港
      • Hong Kong、香港
        • Novartis Investigative Site
      • Kowloon、香港
        • Novartis Investigative Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Placebo
matched placebo tablet administered orally once daily for up to 24 months
薬：Placebo
Matching placebo 800 mg tablet daily, for 104 weeks (24 months).
実験的：Pazopanib
Pazopanib tablet administered orally at 800 mg once daily for up to 24 months
薬：Pazopanib
Pazopanib 800 mg tablet daily for 104 weeks (24 months)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Investigator-assessed Progression-free Survival (PFS)
時間枠：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)
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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival - Median
時間枠：From the date of randomization until the date of death due to any cause up to approximately 25 months
Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.
From the date of randomization until the date of death due to any cause up to approximately 25 months
Overall Survival: Number of Participants Experiencing Death
時間枠：From the date of randomization until the date of death due to any cause up to approximately 25 months
Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.
From the date of randomization until the date of death due to any cause up to approximately 25 months
Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria
時間枠：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)
Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause. Progression is defined according to RECIST but can also be based upon serum CA-125. Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 >=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par. with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 >=2x the nadir value on two occasions at least one week apart or; (3) par. with CA-125 in the normal range pretreatment must show evidence of CA-125 >=2x the UNL on two occasions at least one week apart.
From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)
3-year Progression-free Survival
時間枠：Up to 3 years after randomization
3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization. Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause. Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Up to 3 years after randomization
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
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life. Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 ("poor" to "excellent"). Participants were asked to respond to the following questions using the 7-item Likert scale: "How would you rate your overall health during the past week"; "How would you rate your overall quality of life during the past week?" Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA).
Baseline; Week 13; Months 7, 10, 13, 16, and 25
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
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses attitude to disease/treatment functional symptoms, among others. Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Baseline; Week 13; Months 7, 10, 13, 16, and 25
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
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses body image symptoms, among others. Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?; Have you been dissatisfied with your body? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses peripheral neuropathy symptoms, among others. Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Baseline; Week 13; Months 7, 10, 13, 16, and 25
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
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?; Did you experience any change in bowel habit as a result of your disease or treatment?; Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses hormonal/menopausal symptoms, among others. Participants were asked to indicate the extent to which they experienced hormonal/menopausal symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have hot flashes?; Did you have night sweats? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses sexual functioning symptoms, among others. Participants were asked to indicate the extent to which they experienced sexual functioning problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: To what extent were you interested in sex?; To what extent were you sexually active?; If sexually active, to what extent was sex enjoyable for you?; If sexually active, did you have a dry vagina during sexual activity? Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).
Baseline; Week 13; Months 7, 10, 13, 16, and 25
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
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses other chemotherapy SE symptoms, among others. Participants were asked to indicate the extent to which they experienced other chemotherapy SE symptoms/problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you lost any hair?; If yes, were you upset by the loss of your hair?; Did food/drink taste different from usual?; Did you have aches or pains in your muscles or joints?; Did you have problems with hearing?; Did you urinate frequently?; Have you had skin problems (e.g., itchy, dry)? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The EuroQol (EQ-5D) questionnaire is a 2-page, generic, preference-based quality of life measure comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score The thermometer score is based on a vertical VAS. The VAS is designed like a thermometer scale on which the best health state the participant can imagine is referenced at 100, and the worst health state the participant can imagine is marked by 0. Based on how good or bad the current health state is, the participant is asked to draw a line across the thermometer scale. For example, a line drawn across 46 on the scale of 0 to 100 would be coded 46. A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25
時間枠：Baseline; Week 13; Months 7, 10, 13, 16, and 25
The EQ-5D utility score captures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and/or depression. Participants indicated the level of perceived problems in each of the five dimensions on three levels: 1, no problems; 2, some problems; 3, an extreme problem. Unique health states were defined by combining response levels from each of the five dimensions. For example, state 11111 indicates no problem on any of the five dimensions, whereas state 11223 indicates no problems with mobility or self-care; some problems with performing usual activities, moderate pain/discomfort; and extreme anxiety/depression. Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm
時間枠：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)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade
時間枠：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)
Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0. WBC=White blood cell.
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade
時間枠：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)
Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0.
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)
時間枠：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)
Participants were assessed for thyroid function abnormalities. Clinical hypothyroidism is defined as 5 <TSH <=10 MU/L and T4 <lower limit of normal (LLN).
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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Novartis Pharmaceuticals

協力者

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2009年5月26日

一次修了 (実際)

2012年7月8日

研究の完了 (実際)

2017年8月24日

試験登録日

最初に提出

2009年3月19日

QC基準を満たした最初の提出物

2009年3月19日

最初の投稿 (見積もり)

2009年3月20日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月16日

QC基準を満たした最後の更新が送信されました

2021年1月27日

最終確認日

2021年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 110655
  • 2008-004672-50 (EudraCT番号)
  • CPZP034C2301 (その他の識別子：Novartis)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

卵巣がんの臨床試験

  • Novartis Pharmaceuticals
    終了しました
    進行性固形腫瘍の成人患者におけるTNO155の用量設定研究
    メラノーマ | 高度なEGFR変異体非小さな細胞肺cancer（NSCLC） | KRAS G12変異NSCLC | 食道扁平上皮がん（SCC） | ヘッド/ネックSCC | 進行した胃腸間質腫瘍（GIST） | 進行したNRAS/BRAFT WT皮膚黒色腫
    アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
  • Jonsson Comprehensive Cancer Center
    National Cancer Institute (NCI); Highlight Therapeutics
    積極的、募集していない
    切除可能な軟部肉腫の治療のための手術前のニボルマブと BO-112
    平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件
    アメリカ

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