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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 de fevereiro de 2019 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

191

Estágio

  • Fase 2
  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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
Medicamento: 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.
Outros nomes:
  • Abraxane
Medicamento: Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
Outros nomes:
  • Gemzar
Experimental: 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
Medicamento: 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.
Outros nomes:
  • Abraxane
Medicamento: Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Outros nomes:
  • Paraplatina AQ
  • Paraplatin,
Comparador Ativo: 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
Medicamento: Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
Outros nomes:
  • Gemzar
Medicamento: Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Outros nomes:
  • Paraplatina AQ
  • Paraplatin,

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Celgene

Investigadores

  • Diretor de estudo: Ileana Elias, M.D., Celgene Corporation

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de setembro de 2013

Conclusão Primária (Real)

28 de outubro de 2016

Conclusão do estudo (Real)

28 de outubro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

17 de junho de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de junho de 2013

Primeira postagem (Estimativa)

19 de junho de 2013

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de fevereiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de fevereiro de 2019

Última verificação

1 de fevereiro de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

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