- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027428
Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer
A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)
Maintenance treatment of advanced stage squamous cell NSCLC.
Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin as induction in subjects with stage IIIB/IV squamous cell NSCLC.
Subjects who discontinued treatment from the maintenance part for any reason other than withdrawal of consent, lost to follow-up, or death, were entered into a Follow-up period that had a visit 28 days after progression or discontinuation.
Those who entered Follow-up without progression continued with follow-up scans according to standard of care (SOC) until documentation of progression of disease. Additionally, subjects were followed for OS by phone approximately every 90 days for a minimum of 18 months, for up to approximately 5 years after the last subject was randomized.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Eschweiler, Germany, 52249
- St. Antonius Hospital
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Gauting, Germany, 82131
- Asklepios Fachkliniken Muenchen Gauting
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Halle, Germany, 06120
- Universitatsklinikum Halle Saale
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Halle (Saale), Germany, 6114
- Diakoniekrankenhaus Halle
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Heidelberg, Germany, 69126
- Thorax Klinik
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Homburg, Germany, 66421
- Universität des Saarlandes
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Koln, Germany, 51109
- Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim
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Loewenstein, Germany, 74245
- Klinik Loewenstein gGmbH
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Lostau, Germany, 39291
- Lungenklinik Lostau gGmbH
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Ulm, Germany, 89081
- Universitätsklinikum Ulm
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Avellino, Italy, 83100
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
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Bologna, Italy, 40138
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
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Cremona, Italy, 23100
- Azienda Ospedaliera Istituti Ospitalieri di Cremona
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Genova, Italy, 16132
- Istituto nazionale Per la Ricerca sul Cancro
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Milano, Italy, 20141
- Istituto Europeo di Oncologia
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Monza, Italy, 20900
- Azienda Ospedaliera San Gerardo
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Roma, Italy, 00144
- Istituto Nazionale Tumori Regina Elena di Roma
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Taormina, Italy, 98039
- Ospedale San Vincenzo Taormina
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Girona, Spain, 17007
- Intituto Catalán de Oncología de Girona
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Madrid, Spain, 28040
- Hospital Clinico San Carlos
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Madrid, Spain, 28041
- Hospital Universitario 12 De Octubre
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Majadahonda, Madrid, Spain, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Oviedo, Spain, 33011
- Hospital Universitario Central de Asturias
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Valencia, Spain, 46026
- Hospital Universitari i Politecnic La Fe de Valencia
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Valencia, Spain, 46014
- Hospital General Universitario De Valencia
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Zaragoza, Spain, 50009
- Hospital Universitario Lozano Blesa
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Oxford, United Kingdom, OX3 7LJ
- Churchhill Hospital
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Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hospital
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Alabama
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Huntsville, Alabama, United States, 35805
- Clearview Cancer Institute Oncology Specialties, P.C
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Arizona
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Glendale, Arizona, United States, 85304
- Palo Verde Hematology Oncology, Ltd.
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Tucson, Arizona, United States, 85715
- Arizona Clinical Research Center
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Genesis Cancer Center
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California
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Duarte, California, United States, 91010-3000
- City of Hope Cancer Center
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Fresno, California, United States, 93720
- Cancer Care Associates of Fresno Medical Group Inc
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La Jolla, California, United States, 92093
- University of California San Diego Moores Cancer Center
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Montebello, California, United States, 90640
- Clinical Trials and Research Associates
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Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
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Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers, LLP
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Cancer Center
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Florida
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Boca Raton, Florida, United States, 33486
- Lynn Cancer Institute
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Fort Myers, Florida, United States, 33916
- Florida Cancer Specialists
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Lakeland, Florida, United States, 33805
- Watson Clinic, LLP Center for Cancer Care and Research
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine Jackson Memorial Hospital
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Ocala, Florida, United States, 34474
- Ocala Oncology Center
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Orlando, Florida, United States, 32806
- Orlando Health, Inc
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Pembroke Pines, Florida, United States, 33028
- Memorial Cancer Institute West
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Saint Petersburg, Florida, United States, 33705
- Florida Cancer Specialists
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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Georgia
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Athens, Georgia, United States, 30607
- University Cancer and Blood Center, LLC
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Illinois
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Chicago, Illinois, United States, 60637
- University Of Chicago
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Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates, Ltd.
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Niles, Illinois, United States, 60714
- Illinois Cancer Specialists
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Indiana
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Indianapolis, Indiana, United States, 46260
- Investigative Clinical Research of Indiana, LLC
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Indianapolis, Indiana, United States, 46202-5149
- Indiana University Medical Center
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Kansas
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Westwood, Kansas, United States, 66205
- Kansas University Medical Center
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Wichita, Kansas, United States, 67208
- Cancer Center of Kansas (MAT)
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Kentucky
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Hazard, Kentucky, United States, 41701
- Kentucky Cancer Clinic
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Louisville, Kentucky, United States, 40202
- Norton Healthcare
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Louisville, Kentucky, United States, 40202
- University of Louisville, J.G. Brown Cancer Center
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Louisville, Kentucky, United States, 40207
- Norton Cancer Institute Louisville Oncology
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Louisiana
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New Orleans, Louisiana, United States, 70112
- LSU Health Sciences Center
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Maine
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Auburn, Maine, United States, 04210
- Maine Research Associates
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Brewer, Maine, United States, 04412
- Eastern Maine Medical Center
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Maryland
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Bethesda, Maryland, United States, 20817
- Center for Cancer and Blood Disorders
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Hagerstown, Maryland, United States, 21742
- Meritus Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Beth Israel Deaconess Medical Center
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Michigan
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Farmington Hills, Michigan, United States, 48334
- Detroit Clinical Research Center
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Kalamazoo, Michigan, United States, 49007
- Western Michigan Cancer Center
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Missouri
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Saint Joseph, Missouri, United States, 64507
- St Joseph Oncology
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Springfield, Missouri, United States, 65804
- Mercy Medical Research Institute
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New Jersey
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Englewood, New Jersey, United States, 07631
- Englewood Hospital and Medical Center
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Morristown, New Jersey, United States, 07960
- Hematology-Oncology Associates of NNJ, P
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New York
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Albany, New York, United States, 12206
- New York Oncology Hematology P.C.
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Bronx, New York, United States, 10461
- Montefiore Medical Center
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Bronx, New York, United States, 10467
- Montefiore Medical Center Albert Einstein Cancer Center
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Lake Success, New York, United States, 11042
- Clinical Research Alliance
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Lake Success, New York, United States, 11042
- NYU Langone Medical Center
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai Medical Center
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New York, New York, United States, 10016
- NYU Langone Medical Center
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New York, New York, United States, 10003
- Beth Israel Medical Centers
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Rochester, New York, United States, 14621
- Rochester General Hospital
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Carolinas Medical Center
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Goldsboro, North Carolina, United States, 27534
- Southeastern Medical Oncology Center
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Greensboro, North Carolina, United States, 27403
- Moses H. Cone Regional Cancer Center
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Ohio
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Canton, Ohio, United States, 44708
- Hematology and Oncology Associates, Inc.
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Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care, Inc.
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Cleveland, Ohio, United States, 44106
- University Hospitals Case Medical Center
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Columbus, Ohio, United States, 43219
- The Mark H. Zangmeister Center
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Massillon, Ohio, United States, 44646
- Tri-County Hematology and Oncology Associates
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Toledo, Ohio, United States, 43623
- Toledo Community Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Peggy and Charles Stephenson Cancer Center
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Oklahoma City, Oklahoma, United States, 73102
- Mercy Clinic Oklahoma Communities, Inc.
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Pennsylvania
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Erie, Pennsylvania, United States, 16505
- Erie Regional Cancer Center
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Health Systems
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny Singer Research Institute
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Medical Center - Cancer Pavilion
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South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Hospital System
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Tennessee
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Chattanooga, Tennessee, United States, 37421
- Associates in Oncology and Hematology
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology Hematology Care
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Knoxville, Tennessee, United States, 37916
- Thompson Cancer Survival Center
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Nashville, Tennessee, United States, 37203-1632
- Sarah Cannon Cancer Center
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Texas
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Beaumont, Texas, United States, 77702-1449
- TX Onc, PA- Beaumont
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Fort Sam Houston, Texas, United States, 78235-8200
- Brooke Army Medical Center Francis Street Medical Center
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Fort Worth, Texas, United States, 76104
- Center for Cancer and Blood Disorders
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Houston, Texas, United States, 77030
- Houston Methodist Cancer Center
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Houston, Texas, United States, 77090
- Millenium Oncology
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Houston, Texas, United States, 77030
- UT Health Oncology
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Tyler, Texas, United States, 75702
- TX Onc Tyler Cancer Center
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Washington
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Kennewick, Washington, United States, 99336
- Columbia Basin Hematology and Oncology
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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West Virginia
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Huntington, West Virginia, United States, 25702
- St Mary's Medical Center
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Martinsburg, West Virginia, United States, 25401
- West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
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Morgantown, West Virginia, United States, 26506
- West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years of age at the time of signing the Informed Consent Form.
- Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.
Able to adhere to the study visit schedule and other protocol requirements
Disease Specific
- Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small Cell Lung Cancer at study entry.
- No other current active malignancy requiring anticancer therapy.
- Radiographically documented measurable disease at study entry (as defined by the Response Evaluation Criteria In Solid Tumors [RECIST] v1.1 criteria).
- No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence.
- Absolute neutrophil count ≥ 1500 cells/mm^3.
- Platelets ≥ 100,000 cells/mm^3.
- Hemoglobin ≥ 9 g/dL.
- Aspartate transaminase/serum glutamic oxaloacetic transaminase, alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.
- Total bilirubin ≤ 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.
- Creatinine ≤ 1.5 mg/dL.
- Expected survival of > 12 weeks for the Induction part of the study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
For Maintenance part of the study, subjects must have received at least one dose of nab-paclitaxel in each of the 4 cycles during Induction
Pregnancy
Females of childbearing potential [defined as a sexually mature woman 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:
- agree to take a pregnancy test prior to starting study medication and throughout the study participation.
- commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption, and while receiving study medication or for a longer period if required by local regulations.
Male subjects must:
c. agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication, even if he has undergone a successful vasectomy.
- Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment into the Induction and Maintenance parts of the study (except if specified at study entry only):
- Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to first dose of study drug).
- Only evidence of disease is non-measurable at study entry.
- Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
- Venous thromboembolism within 6 months prior to signing Informed Consent Form.
- Current congestive heart failure (New York Heart Association class II-IV).
- History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
- Treatment with any investigational product within 28 days prior to signing Informed Consent Form.
- History of allergy or hypersensitivity to nab-paclitaxel or carboplatin.
- Currently enrolled in any other clinical protocol or investigational trial that involved administration of experimental therapy and/or therapeutic devices.
- Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol.
- Subject has any other malignancy within 5 years prior to randomization. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b) - all treatments that should have been completed 6 months prior to signing informed consent form (ICF).
- Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product (IP), and/or from whom ≥ 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- Pregnant and nursing females.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Abraxane + Best Supportive Care (BSC)
Dosing will occur in two phases - induction and maintenance.
During induction, the subject will receive Abraxane plus carboplatin as standard of care.
At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase.
Maintenance dosing on this arm includes Abraxane plus best supportive care.
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100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care
Other Names:
6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion
100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, administered as standard of care
The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents
6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion, administered as standard of care
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Other: Best Supportive Care (BSC)
Dosing will occur in two phases - induction and maintenance.
During induction, the subject will receive Abraxane plus carboplatin as standard of care.
At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase.
Maintenance dosing on this arm includes best supportive care only.
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100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care
Other Names:
6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion
The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents
6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion, administered as standard of care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance
Time Frame: From the date of randomization to the date of disease progression or death of any cause; up to data cut off date of 15 September 2017; up to 27.6 months
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Progression-free survival is defined as the time in months from the date of randomization to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by computerized axial tomography [CT scan], not including symptomatic deterioration) or death (any cause) on or prior to 01 Aug 2019.
RECIST 1.1 Definition: - Complete response (CR) -disappearance of all target lesions; - Partial response (PR) -at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease (SD) -neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase of lesions to qualify for progressive disease (PD) - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir, and/or the appearance of new lesions.
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From the date of randomization to the date of disease progression or death of any cause; up to data cut off date of 15 September 2017; up to 27.6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance
Time Frame: From the date of randomization to death from any cause; up to 01 August 2019; survival follow up was 55.89 months
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Overall survival was defined as the duration in months between randomization and death from any cause.
Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off (01 August 2019 whichever was earlier.
The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive.
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From the date of randomization to death from any cause; up to 01 August 2019; survival follow up was 55.89 months
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Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study
Time Frame: Day 1 of treatment in the induction period and subsequent anticancer therapy, death or discontinuation up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study
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Overall response was defined as the percentage of participants with a confirmed assessment of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and confirmed in no less than 28 days.
The 95% confidence interval (CI) was calculated using Clopper-Pearson method.
RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline.
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Day 1 of treatment in the induction period and subsequent anticancer therapy, death or discontinuation up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study
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Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study
Time Frame: Between Day 1 of the Induction Part through to the date of disease progression or death; up to 01 August 2019; the maximum treatment duration was 234.1 weeks for entire study
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PFS was defined as the time in months from Day 1 of treatment for the Induction part to the date of disease progression according to RECIST 1.1 criteria (documented by CT-scan, not including symptomatic deterioration) or death (any cause) on or prior to 01 August 2019, whichever occurred earlier.
RECIST 1.1 Definition: - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of new lesions is also considered progression.
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Between Day 1 of the Induction Part through to the date of disease progression or death; up to 01 August 2019; the maximum treatment duration was 234.1 weeks for entire study
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Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study
Time Frame: Between Day 1 of treatment in the Induction Part to death from any cause; up to 01 August 2019; survival follow up was 55.89 months
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Overall survival was defined as the time in months from Day 1 of treatment for the Induction part to death from any cause.
Subjects who were alive at the time of analysis had their OS censored at the date or last contact of 01 August 2019, whichever was earlier.
The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive.
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Between Day 1 of treatment in the Induction Part to death from any cause; up to 01 August 2019; survival follow up was 55.89 months
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Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) In Maintenance Beyond the Response in Induction
Time Frame: For the induction period the maximum treatment was 19 weeks for the maintenance period the maximum treatment was 150 weeks.
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Overall response in the maintenance period was defined as the percentage of participants who showed an improvement in best overall response from stable disease (SD) or partial response (PR) during Induction to a Complete Response (CR) or PR during Maintenance according to RECIST 1.1 criteria and confirmed in no less than 28 days.
Evaluation takes as reference the lesion measurement or status at the last tumor assessment before randomization to Maintenance.
The 95% CI was calculated using Clopper-Pearson method.
RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. - 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.
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For the induction period the maximum treatment was 19 weeks for the maintenance period the maximum treatment was 150 weeks.
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Percentage of Participants Who Achieved Disease Control (Disease Control Rate) by Investigator Assessment During Induction and Over the Entire Study
Time Frame: Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 induction through maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study
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Disease control rate was defined as the percentage of participants who had radiologic CR, PR or SD for >= 6 weeks according to RECIST 1.1 criteria as determined by the investigator.
Only participants with a confirmed CR/PR are included in this summary.
Two timeframes are offered: - Time to confirmed response within the Induction timeframe.
- Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study.
RECIST 1.1 Definition: - CR- disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - PR- at least a 30% decrease in the sum of diameters of target lesions from baseline; - SD- neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD.
The 95% CI was calculated using Clopper-Pearson method.
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Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 induction through maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study
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Time to Confirmed Response During Induction and Over the Entire Study
Time Frame: Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 Induction through Maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study
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Time to confirmed complete or partial response (CR/PR) is defined as the time from day 1 of treatment in Induction to the first occurrence of confirmed CR/PR.
Two timeframes are offered: - Time to confirmed response within the Induction timeframe.
- Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study.
Only participants with a confirmed CR or PR are included in this summary.
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Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 Induction through Maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study
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Kaplan-Meier Estimate for Duration of Response Over the Entire Study
Time Frame: Between Day 1 of the Induction Period through to the date of disease progression or death; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study.
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Duration of overall response was measured from the time criteria were first met for CR/PR until the first date the recurrent or progressive disease (PD) was radiologically documented.
Participants who did not have PD after the response were censored on the date of last tumor assessment.
If a participant died before PD, the participant was censored on the date of death.
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Between Day 1 of the Induction Period through to the date of disease progression or death; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study.
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Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period
Time Frame: Day 1 of Induction up to Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance)
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TEAE in the Induction part is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and on or before the day of randomization for subjects who entered into the Maintenance part, or, for subjects who did not enter into the Maintenance part, before the treatment discontinuation date plus 28 days or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator.
The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate Grade, 3 = Severe Grade, 4 = Life threatening, Grade 5 = Death.
Relation to study drug was determined by the investigator.
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Day 1 of Induction up to Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance)
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Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study
Time Frame: From Day 1 up to 01 August 2019; (maximum treatment length plus 28 days); the maximum treatment duration was 234.1 weeks for entire study
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TEAE over entire study is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and before the treatment discontinuation date plus 28 days, or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator.
The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death.
Relation to study drug was determined by the investigator.
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From Day 1 up to 01 August 2019; (maximum treatment length plus 28 days); the maximum treatment duration was 234.1 weeks for entire study
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Teng Jin Ong, MD, Celgene
Publications and helpful links
General Publications
- Yardley DA, Coleman R, Conte P, Cortes J, Brufsky A, Shtivelband M, Young R, Bengala C, Ali H, Eakel J, Schneeweiss A, de la Cruz-Merino L, Wilks S, O'Shaughnessy J, Gluck S, Li H, Miller J, Barton D, Harbeck N; tnAcity investigators. nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial. Ann Oncol. 2018 Aug 1;29(8):1763-1770. doi: 10.1093/annonc/mdy201.
- Metts JL, Alazraki AL, Clark D, Amankwah EK, Wasilewski-Masker KJ, George BA, Olson TA, Cash T. Gemcitabine/nab-paclitaxel for pediatric relapsed/refractory sarcomas. Pediatr Blood Cancer. 2018 Sep;65(9):e27246. doi: 10.1002/pbc.27246. Epub 2018 May 17.
- Kim S, Signorovitch JE, Yang H, Patterson-Lomba O, Xiang CQ, Ung B, Parisi M, Marshall JL. Comparative Effectiveness of nab-Paclitaxel Plus Gemcitabine vs FOLFIRINOX in Metastatic Pancreatic Cancer: A Retrospective Nationwide Chart Review in the United States. Adv Ther. 2018 Oct;35(10):1564-1577. doi: 10.1007/s12325-018-0784-z. Epub 2018 Sep 12.
- Weiss J, Gilbert J, Deal AM, Weissler M, Hilliard C, Chera B, Murphy B, Hackman T, Liao JJ, Grilley Olson J, Hayes DN. Induction chemotherapy with carboplatin, nab-paclitaxel and cetuximab for at least N2b nodal status or surgically unresectable squamous cell carcinoma of the head and neck. Oral Oncol. 2018 Sep;84:46-51. doi: 10.1016/j.oraloncology.2018.06.028. Epub 2018 Jul 19.
- Cartwright TH, Parisi M, Espirito JL, Wilson TW, Pelletier C, Patel M, Babiker HM. Clinical Outcomes with First-Line Chemotherapy in a Large Retrospective Study of Patients with Metastatic Pancreatic Cancer Treated in a US Community Oncology Setting. Drugs Real World Outcomes. 2018 Sep;5(3):149-159. doi: 10.1007/s40801-018-0137-x.
- Li F, Zhang H, He M, Liao J, Chen N, Li Y, Zhou S, Palmisano M, Yu A, Pai MP, Yuan H, Sun D. Different Nanoformulations Alter the Tissue Distribution of Paclitaxel, Which Aligns with Reported Distinct Efficacy and Safety Profiles. Mol Pharm. 2018 Oct 1;15(10):4505-4516. doi: 10.1021/acs.molpharmaceut.8b00527. Epub 2018 Sep 21.
- Langer CJ, Kim ES, Anderson EC, Jotte RM, Modiano M, Haggstrom DE, Socoteanu MP, Smith DA, Dakhil C, Konduri K, Berry T, Ong TJ, Sanford A, Amiri K, Goldman JW, Weiss J; ABOUND.70+ Investigators. nab-Paclitaxel-Based Therapy in Underserved Patient Populations: The ABOUND.70+ Study in Elderly Patients With Advanced NSCLC. Front Oncol. 2018 Jul 24;8:262. doi: 10.3389/fonc.2018.00262. eCollection 2018.
- Gajra A, Karim NA, Mulford DA, Villaruz LC, Matrana MR, Ali HY, Santos ES, Berry T, Ong TJ, Sanford A, Amiri K, Spigel DR. nab-Paclitaxel-Based Therapy in Underserved Patient Populations: The ABOUND.PS2 Study in Patients With NSCLC and a Performance Status of 2. Front Oncol. 2018 Jul 24;8:253. doi: 10.3389/fonc.2018.00253. eCollection 2018.
- Pelzer U, Wislocka L, Juhling A, Striefler J, Klein F, Roemmler-Zehrer J, Sinn M, Denecke T, Bahra M, Riess H. Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. Eur J Cancer. 2018 Sep;100:85-93. doi: 10.1016/j.ejca.2018.06.001. Epub 2018 Jul 4.
- Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcon S, Gerber NU, Bisogno G, Fagioli F, Geoerger B, Glade Bender JL, Aerts I, Bergeron C, Hingorani P, Elias I, Simcock M, Ferrara S, Le Bruchec Y, Slepetis R, Chen N, Vassal G. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Eur J Cancer. 2018 Sep;100:27-34. doi: 10.1016/j.ejca.2018.05.002. Epub 2018 Jun 21.
- Topcul M, Ceti N IL, Ozbas Turan S, Kolusayin Ozar MO. In vitro cytotoxic effect of PARP inhibitor alone and in combination with nab-paclitaxel on triple-negative and luminal A breast cancer cells. Oncol Rep. 2018 Jul;40(1):527-535. doi: 10.3892/or.2018.6364. Epub 2018 Apr 12.
- Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.
- Neumann CCM, von Horschelmann E, Reutzel-Selke A, Seidel E, Sauer IM, Pratschke J, Bahra M, Schmuck RB. Tumor-stromal cross-talk modulating the therapeutic response in pancreatic cancer. Hepatobiliary Pancreat Dis Int. 2018 Oct;17(5):461-472. doi: 10.1016/j.hbpd.2018.09.004. Epub 2018 Sep 7.
- Veenstra VL, Damhofer H, Waasdorp C, van Rijssen LB, van de Vijver MJ, Dijk F, Wilmink HW, Besselink MG, Busch OR, Chang DK, Bailey PJ, Biankin AV, Kocher HM, Medema JP, Li JS, Jiang R, Pierce DW, van Laarhoven HWM, Bijlsma MF. ADAM12 is a circulating marker for stromal activation in pancreatic cancer and predicts response to chemotherapy. Oncogenesis. 2018 Nov 16;7(11):87. doi: 10.1038/s41389-018-0096-9.
- Morgensztern D, Cobo M, Ponce Aix S, Postmus PE, Lewanski CR, Bennouna J, Fischer JR, Juan-Vidal O, Stewart DJ, Fasola G, Ardizzoni A, Bhore R, Wolfsteiner M, Talbot DC, Jin Ong T, Govindan R, On Behalf Of The Abound L Investigators. ABOUND.2L+: A randomized phase 2 study of nanoparticle albumin-bound paclitaxel with or without CC-486 as second-line treatment for advanced nonsquamous non-small cell lung cancer (NSCLC). Cancer. 2018 Dec 15;124(24):4667-4675. doi: 10.1002/cncr.31779. Epub 2018 Nov 1.
- Marschner N, Salat C, Soling U, Hansen R, Grebhardt S, Harde J, Nusch A, Potthoff K. Final Effectiveness and Safety Results of NABUCCO: Real-World Data From a Noninterventional, Prospective, Multicenter Study in 697 Patients With Metastatic Breast Cancer Treated With nab-Paclitaxel. Clin Breast Cancer. 2018 Dec;18(6):e1323-e1337. doi: 10.1016/j.clbc.2018.07.010. Epub 2018 Aug 10.
- Watson S, de la Fouchardiere C, Kim S, Cohen R, Bachet JB, Tournigand C, Ferraz JM, Lefevre M, Colin D, Svrcek M, Meurisse A, Louvet C. Oxaliplatin, 5-Fluorouracil and Nab-paclitaxel as perioperative regimen in patients with resectable gastric adenocarcinoma: A GERCOR phase II study (FOXAGAST). Eur J Cancer. 2019 Jan;107:46-52. doi: 10.1016/j.ejca.2018.11.006. Epub 2018 Dec 7. Erratum In: Eur J Cancer. 2019 Sep;118:190.
- Li YF, Zhang C, Zhou S, He M, Zhang H, Chen N, Li F, Luan X, Pai M, Yuan H, Sun D, Li Y. Species difference in paclitaxel disposition correlated with poor pharmacological efficacy translation from mice to humans. Clin Pharmacol. 2018 Nov 8;10:165-174. doi: 10.2147/CPAA.S185449. eCollection 2018.
- Hurria A, Soto-Perez-de-Celis E, Blanchard S, Burhenn P, Yeon CH, Yuan Y, Li D, Katheria V, Waisman JR, Luu TH, Somlo G, Noonan AM, Lee T, Sudan N, Chung S, Rotter A, Arsenyan A, Levi A, Choi J, Rubalcava A, Morrison R, Mortimer JE. A Phase II Trial of Older Adults With Metastatic Breast Cancer Receiving nab-Paclitaxel: Melding the Fields of Geriatrics and Oncology. Clin Breast Cancer. 2019 Apr;19(2):89-96. doi: 10.1016/j.clbc.2018.10.002. Epub 2018 Oct 16.
- Fernandez A, Salgado M, Garcia A, Buxo E, Vera R, Adeva J, Jimenez-Fonseca P, Quintero G, Llorca C, Canabate M, Lopez LJ, Munoz A, Ramirez P, Gonzalez P, Lopez C, Reboredo M, Gallardo E, Sanchez-Canovas M, Gallego J, Guillen C, Ruiz-Miravet N, Navarro-Perez V, De la Camara J, Ales-Diaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3.
- Awasthi N, Schwarz MA, Zhang C, Schwarz RE. Augmentation of Nab-Paclitaxel Chemotherapy Response by Mechanistically Diverse Antiangiogenic Agents in Preclinical Gastric Cancer Models. Mol Cancer Ther. 2018 Nov;17(11):2353-2364. doi: 10.1158/1535-7163.MCT-18-0489. Epub 2018 Aug 30.
- Cristea MC, Frankel P, Synold T, Rivkin S, Lim D, Chung V, Chao J, Wakabayashi M, Paz B, Han E, Lin P, Leong L, Hakim A, Carroll M, Prakash N, Dellinger T, Park M, Morgan RJ. A phase I trial of intraperitoneal nab-paclitaxel in the treatment of advanced malignancies primarily confined to the peritoneal cavity. Cancer Chemother Pharmacol. 2019 Mar;83(3):589-598. doi: 10.1007/s00280-019-03767-9. Epub 2019 Jan 8.
- Hegewisch-Becker S, Aldaoud A, Wolf T, Krammer-Steiner B, Linde H, Scheiner-Sparna R, Hamm D, Janicke M, Marschner N; TPK-Group (Tumour Registry Pancreatic Cancer). Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Int J Cancer. 2019 Mar 1;144(5):981-990. doi: 10.1002/ijc.31751. Epub 2018 Oct 3.
- Wang Z, Huang C, Yang JJ, Song Y, Cheng Y, Chen GY, Yan HH, Ben XS, Wang BC, Xu CR, Jiang BY, Zhou Q, Chen HJ, Wu YL. A randomised phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell lung carcinoma (C-TONG1002). Eur J Cancer. 2019 Mar;109:183-191. doi: 10.1016/j.ejca.2019.01.007. Epub 2019 Feb 7.
- Woo W, Carey ET, Choi M. Spotlight on liposomal irinotecan for metastatic pancreatic cancer: patient selection and perspectives. Onco Targets Ther. 2019 Feb 21;12:1455-1463. doi: 10.2147/OTT.S167590. eCollection 2019.
- Seiwert TY, Foster CC, Blair EA, Karrison TG, Agrawal N, Melotek JM, Portugal L, Brisson RJ, Dekker A, Kochanny S, Gooi Z, Lingen MW, Villaflor VM, Ginat DT, Haraf DJ, Vokes EE. OPTIMA: a phase II dose and volume de-escalation trial for human papillomavirus-positive oropharyngeal cancer. Ann Oncol. 2019 Feb 1;30(2):297-302. doi: 10.1093/annonc/mdy522. Erratum In: Ann Oncol. 2019 Oct 1;30(10):1673.
- De Luca R, Profita G, Cicero G. Nab-paclitaxel in pretreated metastatic breast cancer: evaluation of activity, safety, and quality of life. Onco Targets Ther. 2019 Feb 26;12:1621-1627. doi: 10.2147/OTT.S191519. eCollection 2019.
- Morgensztern D, Ko A, O'Brien M, Ong TJ, Waqar SN, Socinski MA, Postmus PE, Bhore R. Association between depth of response and survival in patients with advanced-stage non-small cell lung cancer treated with first-line chemotherapy. Cancer. 2019 Jul 15;125(14):2394-2399. doi: 10.1002/cncr.32114. Epub 2019 Apr 1.
- Li F, Yuan H, Zhang H, He M, Liao J, Chen N, Li Y, Zhou S, Palmisano M, Yu A, Pai M, Sun D. Neonatal Fc Receptor (FcRn) Enhances Tissue Distribution and Prevents Excretion of nab-Paclitaxel. Mol Pharm. 2019 Jun 3;16(6):2385-2393. doi: 10.1021/acs.molpharmaceut.8b01314. Epub 2019 May 1.
- Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.
- Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.
- Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.
- Thomas M, Spigel DR, Jotte RM, McCleod M, Socinski MA, Page RD, Gressot L, Knoble J, Juan O, Morgensztern D, Isla D, Kim ES, West H, Ko A, Ong TJ, Trunova N, Gridelli C. nab-paclitaxel/carboplatin induction in squamous NSCLC: longitudinal quality of life while on chemotherapy. Lung Cancer (Auckl). 2017 Oct 30;8:207-216. doi: 10.2147/LCTT.S138570. eCollection 2017.
- Mudad R, Patel MB, Margunato-Debay S, Garofalo D, Lal LS. Comparative effectiveness and safety of nab-paclitaxel plus carboplatin vs gemcitabine plus carboplatin in first-line treatment of advanced squamous cell non-small cell lung cancer in a US community oncology setting. Lung Cancer (Auckl). 2017 Oct 19;8:179-190. doi: 10.2147/LCTT.S139647. eCollection 2017.
- Nakao A, Uchino J, Igata F, On R, Ikeda T, Yatsugi H, Hirano R, Sasaki T, Tanimura K, Imabayashi T, Tamiya N, Kaneko Y, Yamada T, Nagata N, Watanabe K, Kishimoto J, Takayama K, Fujita M. Nab-paclitaxel maintenance therapy following carboplatin + nab-paclitaxel combination therapy in chemotherapy naive patients with advanced non-small cell lung cancer: multicenter, open-label, single-arm phase II trial. Invest New Drugs. 2018 Oct;36(5):903-910. doi: 10.1007/s10637-018-0617-6. Epub 2018 May 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- ABI-007-NSCL-003
- 2014-003804-66 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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