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Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) (tnAcity)

2019年2月19日 更新者：Celgene

A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

ABI-007-MBC- 001 is a Phase 2/3, multicenter, open-label, randomized, study that will compare the safety and efficacy of weekly nab-paclitaxel in combination with gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line therapy in female subjects with Estrogen Receptor (ER), Progesterone Receptor (PgR), and human epidermal growth factor receptor 2 (HER2) negative (triple negative) metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer. In the phase 2 portion of the study, the combinations of nab-paclitaxel plus gemcitabine and nab-paclitaxel plus carboplatin will be evaluated, and a comparator arm of gemcitabine combined with carboplatin will be used. In the phase 3 portion of the study, the selected nab-paclitaxel combination treatment will be compared to gemcitabine combined with carboplatin to evaluate progression free survival, safety and tolerability, overall survival, disease control rate and duration of response in women with metastatic triple negative breast cancer.

Due to changes in the treatment landscape since the initiation of this trial, the decision was made not to proceed to the Phase 3 portion of the study.

研究の種類

介入

入学 (実際)

191

段階

  • フェーズ2
  • 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

  • アメリカ
    • Arizona
      • Chandler、Arizona、アメリカ、85224
        • Ironwood Cancer and Research Center
      • Glendale、Arizona、アメリカ、85306
        • Arizona Center for Cancer Care
      • Scottsdale、Arizona、アメリカ、85259
        • Mayo Clinic Arizona
      • Scottsdale、Arizona、アメリカ、85251
        • Arizona Cancer Research Alliance
    • Arkansas
      • Fayetteville、Arkansas、アメリカ、72703
        • Highlands Oncology Group
    • California
      • Anaheim、California、アメリカ、92801
        • Pacific Cancer Medical Center INC
      • Escondido、California、アメリカ、92025
        • California Cancer Associates for Research and Excellence cCARE
      • La Jolla、California、アメリカ、92093
        • University Of California San Diego Moores Cancer Center
      • La Verne、California、アメリカ、91750
        • Wilshire Oncology Medical Group, Inc
      • Los Angeles、California、アメリカ、90045
        • Translational Research Management
      • San Luis Obispo、California、アメリカ、93401
        • Coastal Integrative Cancer Care
      • Santa Maria、California、アメリカ、93454
        • Central Coast Medical Oncology Corporation
      • Santa Rosa、California、アメリカ、95403
        • Redwood Regional Medical Group, INC
    • Florida
      • Boca Raton、Florida、アメリカ、33486
        • Center for Hematology-Oncology
      • Hollywood、Florida、アメリカ、33021
        • Memorial Breast Cancer Center
      • Jacksonville、Florida、アメリカ、32224
        • Mayo Clinic - Jacksonville
      • Miami、Florida、アメリカ、33136
        • University of Miami School of Medicine
      • Saint Petersburg、Florida、アメリカ、33705
        • Florida Cancer Specialists
      • Sarasota、Florida、アメリカ、34232
        • Florida Cancer Specialists
      • West Palm Beach、Florida、アメリカ、33401
        • Florida Cancer Specialists
    • Illinois
      • Joliet、Illinois、アメリカ、60435
        • Joliet Oncology-Hematology Associates, LTD
      • Urbana、Illinois、アメリカ、61801
        • Carle Cancer Center
    • Indiana
      • Indianapolis、Indiana、アメリカ、46254
        • Investigative Clinical Research of Indiana, LLC
    • Louisiana
      • Lafayette、Louisiana、アメリカ、70503
        • University of South Alabama Mitchell Cancer Institute
    • Maryland
      • Baltimore、Maryland、アメリカ、21201
        • University of Maryland School of Med
      • Bethesda、Maryland、アメリカ、20817
        • Center for Cancer and Blood Disorders, PC
    • Michigan
      • Detroit、Michigan、アメリカ、48202-268
        • Henry Ford Medical Center - New Center One
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55407
        • Minnesota Oncology Hematology, PA
      • Rochester、Minnesota、アメリカ、55905
        • Mayo Clinic
    • Missouri
      • Kansas City、Missouri、アメリカ、64132
        • Midwest Physicians Group
      • Saint Louis、Missouri、アメリカ、63131
        • Missouri Baptist Medical Center
    • New Hampshire
      • Hooksett、New Hampshire、アメリカ、03106
        • New Hampshire Oncology Hematology
      • Lebanon、New Hampshire、アメリカ、03756
        • Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center
    • New Jersey
      • Englewood、New Jersey、アメリカ、07631
        • Englewood Hospital and Medical Center
    • New York
      • East Syracuse、New York、アメリカ、13057
        • Hematology Oncology Associates of CNY
      • Lake Success、New York、アメリカ、11042
        • NYU Langone Arena Oncology
      • New York、New York、アメリカ、10021
        • Clinical Research Alliance
    • North Carolina
      • Burlington、North Carolina、アメリカ、27215-8700
        • Alamance Regional Medical Cancer Center
    • Ohio
      • Cincinnati、Ohio、アメリカ、45242
        • Oncology Hematology Care
      • Cincinnati、Ohio、アメリカ、45219
        • University of Cincinnatti
      • Columbus、Ohio、アメリカ、43219
        • Mark H Zangmeister Center
      • Toledo、Ohio、アメリカ、43623
        • Toledo Community Oncology Program
    • Oklahoma
      • Lawton、Oklahoma、アメリカ、73505
        • Cancer Centers of Southwest Oklahoma
    • Oregon
      • Coos Bay、Oregon、アメリカ、97420
        • North Bend Medical Center
      • Portland、Oregon、アメリカ、97213
        • Providence Portland Medical Center
      • Portland、Oregon、アメリカ、97213
        • Northwest Cancer Specialists, P.C. - Hoyt
    • Pennsylvania
      • Langhorne、Pennsylvania、アメリカ、19047
        • St Mary Medical Center
      • Pittsburgh、Pennsylvania、アメリカ、15213
        • Magee Women's Hospital
    • South Carolina
      • Columbia、South Carolina、アメリカ、29210
        • South Carolina Oncology Associates
    • Tennessee
      • Chattanooga、Tennessee、アメリカ、37404
        • Chattanooga Oncology Hematology Associates
      • Nashville、Tennessee、アメリカ、37203
        • Sarah Cannon Cancer Center
    • Texas
      • Dallas、Texas、アメリカ、75231
        • Texas Oncology, PA
      • Dallas、Texas、アメリカ、75246
        • Texas Oncology, PA- Dallas
      • Fort Worth、Texas、アメリカ、76104
        • The Center for Cancer and Blood Disorders
      • Houston、Texas、アメリカ、77030
        • UT Physicians General Medicine
      • San Antonio、Texas、アメリカ、78217
        • Cancer Care Centers of South Texas - Loop
      • Tyler、Texas、アメリカ、75702
        • Texas Oncology P.A.- Tyler
    • Virginia
      • Fredericksburg、Virginia、アメリカ、22408
        • Hematology Oncology Associates of Fredericksburg
      • Portsmouth、Virginia、アメリカ、23704
        • Delta Hematologyoncology Associates
      • Richmond、Virginia、アメリカ、23230
        • Virginia Cancer Institute
    • Washington
      • Spokane、Washington、アメリカ、99208
        • Medical Oncology Associates
    • West Virginia
      • Huntington、West Virginia、アメリカ、25701
        • Edwards Comprehensive Cancer Center
    • Wisconsin
      • Green Bay、Wisconsin、アメリカ、54301
        • Saint Vincent Hospital
      • Milwaukee、Wisconsin、アメリカ、53211
        • Columbia St Marys Cancer Center
  • イギリス
      • Bath、イギリス、BA1 3NG
        • Royal United Hospital
      • London、イギリス、W1G 6AD
        • Sarah Cannon Research Institute UK
      • Manchester、イギリス、M20 4BX
        • The Christie NHS Foundation Trust
      • Middlesex、イギリス、HA62RN
        • The East and North Hertfordshire NHS Trust
      • Sheffield South Yorkshire、イギリス、S10 2SJ
        • Sheffield Teaching Hospitals NHS Foundation Trust
  • イタリア
      • Bologna, Emilia-Romagna、イタリア、40138
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
      • Ferrara、イタリア、44124
        • Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna
      • Genova、イタリア、16132
        • IRCCS AziendaOspedaliera Universitaria San Martino
      • Grosseto、イタリア、58100
        • Presidio Ospedaliero della Misericordia
      • Messina、イタリア、98158
        • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
      • Monza、イタリア、20900
        • Azienda Ospedaliera San Gerardo
      • Napoli, Campania、イタリア、80131
        • Azienda Ospedaliera Universitaria Federico II
      • Napoli, Campania、イタリア、80131
        • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
      • Padova、イタリア、35128
        • Istituto Oncologico Veneto
      • Reggio Emilia、イタリア、42100
        • Arcispedale Santa Maria Nuova
      • Roma、イタリア、00189
        • Azienda Ospedaliera Sant Andrea
      • Roma、イタリア、144
        • Istituto Nazionale Tumori Regina Elena
      • Roma、イタリア、00168
        • Policlinico Universitario A Gemelli
      • Rozzano (MI)、イタリア、20089
        • Istituto Clinico Humanitas
      • Torino, Piemonte、イタリア、10126
        • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
      • Treviglio、イタリア、24047
        • Azienda Ospedaliera Treviglio-Caravaggio
  • オーストラリア
      • Nedlands、オーストラリア、6009
        • Sir Charles Gairdner Hospital
    • Australian Capital Territory
      • Garran、Australian Capital Territory、オーストラリア、2605
        • Canberra Hospital
    • Victoria
      • Frankston、Victoria、オーストラリア、3199
        • Frankston Hospital Oncology Research
      • Wodonga、Victoria、オーストラリア、3690
        • Border Medical Oncology
  • オーストリア
      • Innsbruck、オーストリア、6020
        • Universitaetsklinik Innsbruck
      • Salzburg、オーストリア、5020
        • Salzburger Landkliniken St. Johanns-Spital
      • Vienna、オーストリア、1090
        • Medizinische Universität Wien
  • カナダ
    • Ontario
      • Ottawa、Ontario、カナダ、K1H 8L6
        • Ottawa General Hospital
    • Quebec
      • Montreal、Quebec、カナダ、H2L 4M1
        • CHUM - Notre Dame
      • Quebec City、Quebec、カナダ、G1S4L8
        • Hospital du Saint Scarement Sacrement Laboratory
      • Rimouski、Quebec、カナダ、G5L5T1
        • CSSS de Rimouski Neigette
    • Saskatchewan
      • Regina、Saskatchewan、カナダ、S4T1A5
        • Alan Blair Cancer Centre at Pasqua Hosptial
  • ギリシャ
      • Athens、ギリシャ、11528
        • University of Athens Medical school - Regional General Hospital
      • Athens、ギリシャ、15562
        • IASO General
      • Faliro、ギリシャ、18547
        • Metropolitan Hospital
      • Heraklion、ギリシャ、71110
        • University General Hospital of Heraklion
      • Rio Patras、ギリシャ、26500
        • University General Hospital of Patras
  • スペイン
      • Barcelona、スペイン、08036
        • Clinic Barcelona Hospital Universitari
      • Barcelona、スペイン、8035
        • Hospital Universitario Vall D hebron
      • Cordoba、スペイン、14004
        • Hospital Universitario Reina Sofia
      • Madrid、スペイン、28007
        • Hospital General Gregorio Marañón
      • San Sebastian、スペイン、20014
        • Onkologikoa - Kutxaren Institutu Onkologikoa
      • Santiago de Compostela、スペイン、15706
        • Hospital Clínico Universitario de Santiago
      • Sevilla、スペイン、41071
        • Hospital Universitario Virgen Macarena
      • Zaragoza、スペイン、50009
        • Hospital Universitario Miguel Servet
  • ドイツ
      • Berlin、ドイツ、10713
        • Sankt Gertrauden-Krankenhaus
      • Bonn、ドイツ、53111
        • Facharztpraxis fur Gynakologie und Geburtshilfe
      • Frankfurt、ドイツ、60431
        • Agaplesion Markus Krankenhaus
      • Freiburg、ドイツ、79110
        • Praxis für interdisziplinäre Onkologie & Hämatologie
      • Heidelberg、ドイツ、69120
        • Universitaetsklinikum Heidelberg
      • Hildesheim、ドイツ、31134
        • Frauenärzte am Bahnhofsplatz
      • Köln、ドイツ、50679
        • Schwerpunktpraxis fur Gynakologische Onkologie
      • München、ドイツ、81377
        • LMU Klinikum der Universität
      • Trier、ドイツ、54290
        • Krankenanstalt Mutterhaus der Borromaerinnen
      • Ulm、ドイツ、89075
        • Universitätsklinikum Ulm
  • フランス
      • Clermont-Ferrand、フランス、63003
        • Centre Jean Perrin
  • ブラジル
      • Fortaleza、ブラジル、60160-230
        • ONCOCLINIC Clinica de Oncologia LTDA
      • Ribeirao Preto、ブラジル、14015-130
        • Instituto Ribeiraopretano de Combate Ao Cancer
      • Ribeirao Preto、ブラジル、14048-900
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • Rio Grande Do Sul、ブラジル、95900-000
        • Hospital Bruno Born
      • Sao Jose Do Rio Preto、ブラジル、15090-000
        • Hospital de Base Da Faculdade de Medicina de
      • Sao Paulo、ブラジル、05651-901
        • Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira
      • São Paulo、ブラジル、01308-050
        • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
      • São Paulo、ブラジル、03102-002
        • Instituto Brasileiro de Controle do Cancer Ibcc
    • Bahia
      • Salvador、Bahia、ブラジル、41820-021
        • Centro de Oncologia da Bahia
    • Paraná
      • Curitiba、Paraná、ブラジル、81520-060
        • Liga Paranaense de Combate ao Cancer
    • Rio De Janeiro
      • Rio De Janerio、Rio De Janeiro、ブラジル、20560-120
        • Instituto Nacional de Cancer - INCA
    • Rio Grande Do Sul
      • Porto Alegre、Rio Grande Do Sul、ブラジル、90035-001
        • Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento
      • Porto Alegre、Rio Grande Do Sul、ブラジル、90610-000
        • Hospital Sao Lucas - PUCRS
    • São Paulo
      • Barretos、São Paulo、ブラジル、14784-400
        • Fundacao Pio XII - Hospital de Cancer de Barretos
      • Jau/SP、São Paulo、ブラジル、17210-080
        • Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú
  • ポルトガル
      • Evora、ポルトガル、7000-811
        • Hospital Espírito Santo
      • Lisboa、ポルトガル、1500-650
        • Hospital da Luz
      • Lisboa、ポルトガル、1649-035
        • Hospital de Santa Maria
      • Porto、ポルトガル、4200-072
        • Instituto Portugues de Oncologia do Porto, Francisco Gentil

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: A subject will be eligible for inclusion in this study only if all of the following criteria are met:

  1. Female subjects, age ≥ 18 years at the time informed consent is signed
  2. Pathologically confirmed adenocarcinoma of the breast

  3. Pathologically confirmed as triple negative, source documented, defined as both of the following

    1. Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: < 1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)
    2. Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines i. Immunohistochemistry (IHC) 0 or 1 Fluorescence In Situ Hybridization (FISH) negative (or equivalent negative test). Subjects with IHC 2 must have a negative by Fluorescence In Situ Hybridization (FISH),, (or equivalent negative test).
  4. Subjects with prior breast cancer history of different phenotypes (ie, ER/PgR/HER2 positive) must have pathologic confirmation of triple negative disease in at least one of the current sites of metastasis

  5. Subjects must have received prior adjuvant or neoadjuvant anthracycline therapy; unless (a) anthracycline treatment was not indicated or was not the best treatment option for the subject in the opinion of the treating physician; and (b) anthracycline treatment remains not indicated or, in the opinion of the treating physician, is not the best treatment option for the subject's metastatic disease.

    a. Newly diagnosed subjects presenting with TNMBC are eligible for the study if anthracycline treatment is not indicated or is not the best treatment option for the subject in the opinion of the treating physician.

  6. Subjects with measurable metastatic disease, defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) guidelines
  7. Life expectancy ≥ 16 weeks from randomization
  8. No prior cytotoxic chemotherapy for metastatic breast cancer. Prior immunotherapy and/or monoclonal antibody therapy are acceptable. Prior treatments must have been discontinued at least 30 days prior to start of study treatment and all related toxicities must have resolved to Grade 1 or less.

  9. Prior neoadjuvant or adjuvant chemotherapy, if given, must have been completed at least 6 months before randomization with all related toxicities resolved, and documented evidence of disease progression per RECIST 1.1 guidelines is required.

    a. If prior neoadjuvant or adjuvant chemotherapy contained taxane, gemcitabine, or platinum agents, the treatment must have completed at least 12 months before randomization

  10. Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. At least one measurable lesion must be completely outside the radiation portal or there must be unequivocal radiologic or clinical exam proof of progressive disease within the radiation portal, in accordance with RECIST 1.1 guidelines
  11. At least 30 days from major surgery before randomization, with full recovery
  12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  13. Subject has the following blood counts at screening:

    • Absolute Neutrophil Count (ANC) ≥ 1500/mm^2 ;
    • Platelets ≥ 100,000/mm^2 ;
    • Hemoglobin (Hgb) ≥ 9 g/dL

  14. Subject has the following blood chemistry levels at screening:

    • Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), Alanine Aminotransferase (ALT ) Serum Glutamic Pyruvate Transaminase (SGPT) ≤ 2.5 x upper limit of normal range (ULN); if hepatic metastases present ≤ 5.0 x ULN
    • Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in subjects with documented Gilbert's Syndrome
    • Creatinine clearance > 60 mL/min (by Cockcroft-Gault)

  15. Females of child-bearing potential [defined as a sexually mature women who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)] must:

    • Demonstrate a negative serum pregnancy test result at screening (performed by central lab) confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of IP); pregnancy test with sensitivity of at least 25 mIU/mL; and
    • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, two physician approved effective contraception methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption for 28 days or longer as required by local guidelines, prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of the study or longer as required by local guidelines
  16. Females must abstain from breastfeeding starting at randomization, during study participation and for 28 days or longer as required by local guidelines, after IP discontinuation
  17. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
  18. Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  1. Male subjects
  2. Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Prior immunotherapy & monoclonal antibody therapy are acceptable.
  3. Subjects who received prior cytotoxic chemotherapy after incomplete resection of locoregional recurrent disease
  4. History of, or known current evidence of brain metastasis, including leptomeningeal involvement.
  5. Subjects with bone as the only site of metastatic disease
  6. Subjects with regional lymph node as the only site of metastatic disease
  7. Serious intercurrent medical or psychiatric illness, including serious active infection
  8. History of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization
  9. History of other primary malignancy in the last 5 years prior to randomization. Subjects with prior breast cancer history are eligible, however, the most recently obtained biopsy must demonstrate triple negative disease (source documented). Subjects with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.
  10. Subjects with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple uncontrolled or unstable allergies which, in the opinion of the investigator, may lead to serious complications
  11. Peripheral neuropathy Grade ≥ 2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
  12. Subjects who have received an investigational product within the previous 4 weeks prior to randomization
  13. Subject is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study
  14. Pregnant or nursing women
  15. Subjects with prior hypersensitivity to nab-paclitaxel, gemcitabine, carboplatin or any other platin, or nucleoside analogue agents
  16. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  17. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
  18. Any condition that confounds the ability to interpret data from the study
  19. History of seropositive human immunodeficiency virus (HIV)
  20. Subjects who are receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications

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
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：nab-Paclitaxel plus Gemcitabine
Treatment Arm A: nab-Paclitaxel 125 mg/m^2 by intravenous (IV) administration over 30 minutes, followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day cycle by IV administration over 30 minutes
薬：nab-Paclitaxel
nab-Paclitaxel 125 mg/m^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.
他の名前：
  • アブラキサン
薬：Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
他の名前：
  • ジェムザール
実験的：nab-Paclitaxel plus Carboplatin
Treatment Arm B: nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin at an Area Under the Curve (AUC) of 2 on Days 1 and 8 of each 21-day cycle by IV administration
薬：nab-Paclitaxel
nab-Paclitaxel 125 mg/m^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.
他の名前：
  • アブラキサン
薬：Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
他の名前：
  • パラプラチンAQ
  • Paraplatin,
アクティブコンパレータ：Gemcitabine plus Carboplatin
Treatment Arm C: Gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin AUC 2 on Days 1 and 8 of each 21-day cycle by IV administration
薬：Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
他の名前：
  • ジェムザール
薬：Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
他の名前：
  • パラプラチンAQ
  • Paraplatin,

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
Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.
時間枠：From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C
PFS was defined as the time from the date of randomization to the date of disease progression or death from any cause on or prior to the data cutoff date for the statistical analysis, whichever occurred earlier. Tumor responses were assessed every 6 weeks using, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and defined as: Complete response (CR) is the disappearance of all target lesions; Partial response (PR) occurs when at least a 30% decrease in the sum of diameters of target lesions from baseline; Stable disease is neither sufficient shrinkage to qualify for a PR nor sufficient increase of lesions to qualify for Progressive disease (PD); Progressive Disease- is at least a 20% increase in the sum of diameters of target lesions from nadir.
From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.
時間枠：Disease response was assessed every 6 weeks; from date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C
Percentage of participants with an Objective Complete or Partial Overall Response according to RECIST 1.1 and defined as: Complete response-disappearance of all target lesions; partial response at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.
Disease response was assessed every 6 weeks; from date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C
Percentage of Participants Who Initiated Cycle 6 Receiving Doublet Combination Therapy
時間枠：Cycle 6
The percentage of participants who initiated Cycle 6 receiving doublet combination therapy regardless of the need for dose modifications.
Cycle 6
Kaplan-Meier Estimates of Overall Survival
時間枠：From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C
Overall survival was defined as the time from the date of randomization to the date of death (from any cause).
From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
時間枠：From randomization through to 28 days after the last dose of IP; up to data cut off date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C
Treatment-emergent adverse events (TEAEs) were defined as any AEs that began or worsened with the onset date on or after the date of the first dose of IP through 28 days after the last dose. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was graded based on the participant's symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity as follows: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death.
From randomization through to 28 days after the last dose of IP; up to data cut off date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C
Percentage of Participants Experiencing Dose Modifications (Reductions and Interruptions)
時間枠：From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C
The number of participants with dose modifications occurring during the treatment period. Dose reductions and interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C
Percentage of Participants Who Discontinued From All Study Treatment Due to TEAEs
時間枠：From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C
Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen with an onset date on or after the date of the first dose of IP through 28 days after the last dose.
From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C

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

Celgene

捜査官

  • スタディディレクター：Ileana Elias, M.D.、Celgene Corporation

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)

2013年9月26日

一次修了 (実際)

2016年10月28日

研究の完了 (実際)

2016年10月28日

試験登録日

最初に提出

2013年6月17日

QC基準を満たした最初の提出物

2013年6月17日

最初の投稿 (見積もり)

2013年6月19日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月21日

QC基準を満たした最後の更新が送信されました

2019年2月19日

最終確認日

2019年2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

  • ABI-007-MBC-001
  • 2013-000113-20 (EudraCT番号)

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