이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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)

2019년 2월 19일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

191

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
의약품: 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.
다른 이름들:
  • 아브락산
의약품: Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
다른 이름들:
  • 젬자
실험적: 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
의약품: 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.
다른 이름들:
  • 아브락산
의약품: Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
다른 이름들:
  • 파라플라틴 AQ
  • Paraplatin,
활성 비교기: 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
의약품: Gemcitabine
Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
다른 이름들:
  • 젬자
의약품: Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
다른 이름들:
  • 파라플라틴 AQ
  • Paraplatin,

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Celgene

수사관

  • 연구 책임자: Ileana Elias, M.D., Celgene Corporation

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2013년 9월 26일

기본 완료 (실제)

2016년 10월 28일

연구 완료 (실제)

2016년 10월 28일

연구 등록 날짜

최초 제출

2013년 6월 17일

QC 기준을 충족하는 최초 제출

2013년 6월 17일

처음 게시됨 (추정)

2013년 6월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 2월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 2월 19일

마지막으로 확인됨

2019년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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