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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)

19 февраля 2019 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

191

Фаза

  • Фаза 2
  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Женский

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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
Лекарство: 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.
Другие имена:
  • Абраксан
Лекарство: Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
Другие имена:
  • Гемзар
Экспериментальный: 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
Лекарство: 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.
Другие имена:
  • Абраксан
Лекарство: Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Другие имена:
  • Параплатин AQ
  • Paraplatin,
Активный компаратор: 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
Лекарство: Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
Другие имена:
  • Гемзар
Лекарство: Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Другие имена:
  • Параплатин AQ
  • Paraplatin,

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Celgene

Следователи

  • Директор по исследованиям: Ileana Elias, M.D., Celgene Corporation

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

26 сентября 2013 г.

Первичное завершение (Действительный)

28 октября 2016 г.

Завершение исследования (Действительный)

28 октября 2016 г.

Даты регистрации исследования

Первый отправленный

17 июня 2013 г.

Впервые представлено, что соответствует критериям контроля качества

17 июня 2013 г.

Первый опубликованный (Оценивать)

19 июня 2013 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

21 февраля 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

19 февраля 2019 г.

Последняя проверка

1 февраля 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования nab-Paclitaxel

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