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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. februar 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

191

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
      • Nedlands, Australia, 6009
        • Sir Charles Gairdner Hospital
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital Oncology Research
      • Wodonga, Victoria, Australia, 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
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM - Notre Dame
      • Quebec City, Quebec, Canada, G1S4L8
        • Hospital du Saint Scarement Sacrement Laboratory
      • Rimouski, Quebec, Canada, G5L5T1
        • CSSS de Rimouski Neigette
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T1A5
        • Alan Blair Cancer Centre at Pasqua Hosptial
  • Forente stater
    • Arizona
      • Chandler, Arizona, Forente stater, 85224
        • Ironwood Cancer and Research Center
      • Glendale, Arizona, Forente stater, 85306
        • Arizona Center for Cancer Care
      • Scottsdale, Arizona, Forente stater, 85259
        • Mayo Clinic Arizona
      • Scottsdale, Arizona, Forente stater, 85251
        • Arizona Cancer Research Alliance
    • Arkansas
      • Fayetteville, Arkansas, Forente stater, 72703
        • Highlands Oncology Group
    • California
      • Anaheim, California, Forente stater, 92801
        • Pacific Cancer Medical Center INC
      • Escondido, California, Forente stater, 92025
        • California Cancer Associates for Research and Excellence cCARE
      • La Jolla, California, Forente stater, 92093
        • University Of California San Diego Moores Cancer Center
      • La Verne, California, Forente stater, 91750
        • Wilshire Oncology Medical Group, Inc
      • Los Angeles, California, Forente stater, 90045
        • Translational Research Management
      • San Luis Obispo, California, Forente stater, 93401
        • Coastal Integrative Cancer Care
      • Santa Maria, California, Forente stater, 93454
        • Central Coast Medical Oncology Corporation
      • Santa Rosa, California, Forente stater, 95403
        • Redwood Regional Medical Group, INC
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Center for Hematology-Oncology
      • Hollywood, Florida, Forente stater, 33021
        • Memorial Breast Cancer Center
      • Jacksonville, Florida, Forente stater, 32224
        • Mayo Clinic - Jacksonville
      • Miami, Florida, Forente stater, 33136
        • University of Miami School of Medicine
      • Saint Petersburg, Florida, Forente stater, 33705
        • Florida Cancer Specialists
      • Sarasota, Florida, Forente stater, 34232
        • Florida Cancer Specialists
      • West Palm Beach, Florida, Forente stater, 33401
        • Florida Cancer Specialists
    • Illinois
      • Joliet, Illinois, Forente stater, 60435
        • Joliet Oncology-Hematology Associates, LTD
      • Urbana, Illinois, Forente stater, 61801
        • Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46254
        • Investigative Clinical Research of Indiana, LLC
    • Louisiana
      • Lafayette, Louisiana, Forente stater, 70503
        • University of South Alabama Mitchell Cancer Institute
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • University of Maryland School of Med
      • Bethesda, Maryland, Forente stater, 20817
        • Center for Cancer and Blood Disorders, PC
    • Michigan
      • Detroit, Michigan, Forente stater, 48202-268
        • Henry Ford Medical Center - New Center One
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55407
        • Minnesota Oncology Hematology, PA
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, Forente stater, 64132
        • Midwest Physicians Group
      • Saint Louis, Missouri, Forente stater, 63131
        • Missouri Baptist Medical Center
    • New Hampshire
      • Hooksett, New Hampshire, Forente stater, 03106
        • New Hampshire Oncology Hematology
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center
    • New Jersey
      • Englewood, New Jersey, Forente stater, 07631
        • Englewood Hospital and Medical Center
    • New York
      • East Syracuse, New York, Forente stater, 13057
        • Hematology Oncology Associates of CNY
      • Lake Success, New York, Forente stater, 11042
        • NYU Langone Arena Oncology
      • New York, New York, Forente stater, 10021
        • Clinical Research Alliance
    • North Carolina
      • Burlington, North Carolina, Forente stater, 27215-8700
        • Alamance Regional Medical Cancer Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45242
        • Oncology Hematology Care
      • Cincinnati, Ohio, Forente stater, 45219
        • University of Cincinnatti
      • Columbus, Ohio, Forente stater, 43219
        • Mark H Zangmeister Center
      • Toledo, Ohio, Forente stater, 43623
        • Toledo Community Oncology Program
    • Oklahoma
      • Lawton, Oklahoma, Forente stater, 73505
        • Cancer Centers of Southwest Oklahoma
    • Oregon
      • Coos Bay, Oregon, Forente stater, 97420
        • North Bend Medical Center
      • Portland, Oregon, Forente stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forente stater, 97213
        • Northwest Cancer Specialists, P.C. - Hoyt
    • Pennsylvania
      • Langhorne, Pennsylvania, Forente stater, 19047
        • St Mary Medical Center
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • Magee Women's Hospital
    • South Carolina
      • Columbia, South Carolina, Forente stater, 29210
        • South Carolina Oncology Associates
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37404
        • Chattanooga Oncology Hematology Associates
      • Nashville, Tennessee, Forente stater, 37203
        • Sarah Cannon Cancer Center
    • Texas
      • Dallas, Texas, Forente stater, 75231
        • Texas Oncology, PA
      • Dallas, Texas, Forente stater, 75246
        • Texas Oncology, PA- Dallas
      • Fort Worth, Texas, Forente stater, 76104
        • The Center for Cancer and Blood Disorders
      • Houston, Texas, Forente stater, 77030
        • UT Physicians General Medicine
      • San Antonio, Texas, Forente stater, 78217
        • Cancer Care Centers of South Texas - Loop
      • Tyler, Texas, Forente stater, 75702
        • Texas Oncology P.A.- Tyler
    • Virginia
      • Fredericksburg, Virginia, Forente stater, 22408
        • Hematology Oncology Associates of Fredericksburg
      • Portsmouth, Virginia, Forente stater, 23704
        • Delta Hematologyoncology Associates
      • Richmond, Virginia, Forente stater, 23230
        • Virginia Cancer Institute
    • Washington
      • Spokane, Washington, Forente stater, 99208
        • Medical Oncology Associates
    • West Virginia
      • Huntington, West Virginia, Forente stater, 25701
        • Edwards Comprehensive Cancer Center
    • Wisconsin
      • Green Bay, Wisconsin, Forente stater, 54301
        • Saint Vincent Hospital
      • Milwaukee, Wisconsin, Forente stater, 53211
        • Columbia St Marys Cancer Center
  • Frankrike
      • Clermont-Ferrand, Frankrike, 63003
        • Centre Jean Perrin
  • Hellas
      • Athens, Hellas, 11528
        • University of Athens Medical school - Regional General Hospital
      • Athens, Hellas, 15562
        • IASO General
      • Faliro, Hellas, 18547
        • Metropolitan Hospital
      • Heraklion, Hellas, 71110
        • University General Hospital of Heraklion
      • Rio Patras, Hellas, 26500
        • University General Hospital of Patras
  • Italia
      • Bologna, Emilia-Romagna, Italia, 40138
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
      • Ferrara, Italia, 44124
        • Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna
      • Genova, Italia, 16132
        • IRCCS AziendaOspedaliera Universitaria San Martino
      • Grosseto, Italia, 58100
        • Presidio Ospedaliero della Misericordia
      • Messina, Italia, 98158
        • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
      • Monza, Italia, 20900
        • Azienda Ospedaliera San Gerardo
      • Napoli, Campania, Italia, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Napoli, Campania, Italia, 80131
        • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
      • Padova, Italia, 35128
        • Istituto Oncologico Veneto
      • Reggio Emilia, Italia, 42100
        • Arcispedale Santa Maria Nuova
      • Roma, Italia, 00189
        • Azienda Ospedaliera Sant Andrea
      • Roma, Italia, 144
        • Istituto Nazionale Tumori Regina Elena
      • Roma, Italia, 00168
        • Policlinico Universitario A Gemelli
      • Rozzano (MI), Italia, 20089
        • Istituto Clinico Humanitas
      • Torino, Piemonte, Italia, 10126
        • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
      • Treviglio, Italia, 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
  • Spania
      • Barcelona, Spania, 08036
        • Clinic Barcelona Hospital Universitari
      • Barcelona, Spania, 8035
        • Hospital Universitario Vall D hebron
      • Cordoba, Spania, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spania, 28007
        • Hospital General Gregorio Marañón
      • San Sebastian, Spania, 20014
        • Onkologikoa - Kutxaren Institutu Onkologikoa
      • Santiago de Compostela, Spania, 15706
        • Hospital Clínico Universitario de Santiago
      • Sevilla, Spania, 41071
        • Hospital Universitario Virgen Macarena
      • Zaragoza, Spania, 50009
        • Hospital Universitario Miguel Servet
  • Storbritannia
      • Bath, Storbritannia, BA1 3NG
        • Royal United Hospital
      • London, Storbritannia, W1G 6AD
        • Sarah Cannon Research Institute UK
      • Manchester, Storbritannia, M20 4BX
        • The Christie NHS Foundation Trust
      • Middlesex, Storbritannia, HA62RN
        • The East and North Hertfordshire NHS Trust
      • Sheffield South Yorkshire, Storbritannia, S10 2SJ
        • Sheffield Teaching Hospitals NHS Foundation Trust
  • Tyskland
      • Berlin, Tyskland, 10713
        • Sankt Gertrauden-Krankenhaus
      • Bonn, Tyskland, 53111
        • Facharztpraxis fur Gynakologie und Geburtshilfe
      • Frankfurt, Tyskland, 60431
        • Agaplesion Markus Krankenhaus
      • Freiburg, Tyskland, 79110
        • Praxis für interdisziplinäre Onkologie & Hämatologie
      • Heidelberg, Tyskland, 69120
        • Universitaetsklinikum Heidelberg
      • Hildesheim, Tyskland, 31134
        • Frauenärzte am Bahnhofsplatz
      • Köln, Tyskland, 50679
        • Schwerpunktpraxis fur Gynakologische Onkologie
      • München, Tyskland, 81377
        • LMU Klinikum der Universität
      • Trier, Tyskland, 54290
        • Krankenanstalt Mutterhaus der Borromaerinnen
      • Ulm, Tyskland, 89075
        • Universitätsklinikum Ulm
  • Østerrike
      • Innsbruck, Østerrike, 6020
        • Universitaetsklinik Innsbruck
      • Salzburg, Østerrike, 5020
        • Salzburger Landkliniken St. Johanns-Spital
      • Vienna, Østerrike, 1090
        • Medizinische Universität Wien

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 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.
Andre navn:
  • Abraxane
Legemiddel: Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
Andre navn:
  • Gemzar
Eksperimentell: 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
Legemiddel: 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.
Andre navn:
  • Abraxane
Legemiddel: Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Andre navn:
  • Paraplatin AQ
  • Paraplatin,
Aktiv komparator: 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
Legemiddel: Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
Andre navn:
  • Gemzar
Legemiddel: Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Andre navn:
  • Paraplatin AQ
  • Paraplatin,

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Celgene

Etterforskere

  • Studieleder: Ileana Elias, M.D., Celgene Corporation

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. september 2013

Primær fullføring (Faktiske)

28. oktober 2016

Studiet fullført (Faktiske)

28. oktober 2016

Datoer for studieregistrering

Først innsendt

17. juni 2013

Først innsendt som oppfylte QC-kriteriene

17. juni 2013

Først lagt ut (Anslag)

19. juni 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. februar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. februar 2019

Sist bekreftet

1. februar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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