Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

November 7, 2019 updated by: Celgene

A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas

Phase III Metastatic Pancreatic Cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the pancreas.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
861

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown-Lidcombe Hospital
      • Campbelltown, New South Wales, Australia, 2560
        • Macarthur Cancer Therapy Center
      • Concord, New South Wales, Australia, 2139
        • Concord Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Waratah, New South Wales, Australia, 2298
        • Newcastle Hospital
      • Wollongong, New South Wales, Australia, 2500
        • Southern Medical Day Care Centre
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Milton, Queensland, Australia, 4101
        • Haemotology & Oncology Australasia (HOCA)
      • Milton, Queensland, Australia, 4215
        • Haematology Oncology Clinics of Australasia-Gold Coast
    • South Australia
      • Ashford, South Australia, Australia, 5035
        • Adelaide Cancer Centre (T/A Ashford Cancer Ctr)
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Center
      • North Adelaide, South Australia, Australia, 5006
        • Calvary North Adelaide Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Bendigo, Victoria, Australia, 3552
        • Medical Oncology Unit, Bendigo Health
      • East Bentleigh, Victoria, Australia, 3165
        • Monash Medical Centre
      • Footscray, Victoria, Australia, 3011
        • Western Hospital
      • Frankston, Victoria, Australia, 3199
        • Peninsula Oncology Centre
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology
    • Western Australia
      • Nedlands, Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Austria
      • Linz, Austria, 4010
        • Krankenhaus Der Barmherzigen Schwestern Linz
      • St. Pölten, Austria, 3100
        • Landesklinikum St. Pölten
      • Vienna, Austria, 1090
        • Medizinische Universität Wien
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda VZW , Gastro-Enterology
      • Brussels, Belgium, 1070
        • Hôpital Erasme, Gastro-Enterology
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Campus Sint-Niklaas
      • Roeselare, Belgium, 8800
        • H.-Hartziekenhuis Roeselare-Menen VZW
  • Canada
      • Montreal, Canada, H2X3J4
        • Centre Hospitalier de L'Universite de Montreal St-Luc
      • Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Quebec, Canada, G1R 2J6
        • Hotel-Dieu de Quebec
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency-Vancouver
    • Ontario
      • Barrie, Ontario, Canada, L4M6M2
        • The Royal Victoria Hospital-Barrie
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital Du Sacre-Coeur
  • France
      • Angers, France, 49933
        • Centre Regional de lutte contre le cancer Paul Papin
      • Paris, France, 75571
        • Hôpital Saint Antoine
      • Paris, France, 92118
        • Hôpital Beaujon
  • Germany
      • Essen, Germany, 45136
        • Kliniken Essen-Mitte
      • Freising, Germany, 85354
        • Klinikum Freising
      • Friedrichshafen, Germany, 88045
        • Praxis für Innere Medizin, Dr. Oettle Helmut
      • Munich, Germany, 81377
        • LMU Klinikum der Universität
      • Oldenburg, Germany, 26133
        • Klinikum Oldenburg
      • Würzburg, Germany, 97070
        • Universitätsklinikum Würzburg
  • Italy
      • Bari, Italy, 70124
        • I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico
      • Genova, Italy, 16128
        • E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica
      • Genova, Italy, 16132
        • Nazionale per la Ricerca sul Cancro
      • Milano, Italy, 20132
        • Fondazione Centro San Raffaele del Monte Tabor
      • Milano, Italy, 20162
        • Oncologia Medica Falck
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto
      • Pavia, Italy, 27100
        • IRCCS Policlinico San Matteo
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Reggio Emilia, Italy, 42100
        • Arcispedale Santa Maria Nuova
      • Reggio Emilia, Italy, 42100
        • Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica
      • Roma, Italy, 00144
        • Istituto Nazionale Tumori "Regina Elena"
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Ospedale Casa Sollievo Della Sofferenza IRCCS
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata di Verona
  • Russian Federation
      • Barnaul, Russian Federation, 656049
        • Altai Territorial Oncological Center
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Onc Ctr
      • Ivanovo, Russian Federation, 153013
        • Ivanovo Regional Oncology Center
      • Magnitogorsk, Russian Federation, 455001
        • Regional Oncological Center # 2
      • Moscow, Russian Federation, 105077
        • Moscow City Clinical Hosp #57 Chemotherapy Dept
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center
      • Moscow, Russian Federation, 117997
        • Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care
      • Moscow, Russian Federation, 119992
        • Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences
      • Moscow, Russian Federation, 121356
        • Central Clinical Hosp of the President of the Russian Federation
      • Moscow, Russian Federation, 129128
        • Semashko Central Hosp #2
      • Moscow Region, Russian Federation, 143423
        • Moscow Municipal Onc Hosp #62
      • Omsk, Russian Federation, 610013
        • Omsk Regional Onc Ctr
      • Orenburg, Russian Federation, 460021
        • Orenburg Regional Onc Ctr
      • Pyatigorsk, Russian Federation, 357500
        • Pyatigorsk Affiliate of Stavropol Regional Onc Ctr
      • St Petersburg, Russian Federation, 195067
        • St. Petersburg State Med Academy n.a.Mechnikov
      • St Petersburg, Russian Federation, 197758
        • Russian Research Ctr for Radiology and Surgical Technologies
      • St. Petersburg, Russian Federation, 194291
        • Clinical Hosp # 122 n.a. L.G. Sokolov
      • St. Petersburg, Russian Federation, 194291
        • Leningrad Regional Clinical Hosp
      • St. Petersburg, Russian Federation, 198255
        • St. Petersburg City Onc Ctr
      • Tula, Russian Federation, 300053
        • Tula Regional Oncology Center
      • Ufa, Russian Federation, 450054
        • Bashkortostan Republican Onc Ctr
      • Yaroslavl, Russian Federation, 150054
        • Yaroslavl Regional Onc Ctr
    • Kaluga Region
      • Obninsk, Kaluga Region, Russian Federation, 249036
        • Med Radiological Centre of the Russian Academy of Med Sciences
    • Republic Of Tatarstan
      • Kazan, Republic Of Tatarstan, Russian Federation, 420029
        • Tatarstan Republican Onc Ctr
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d´Hebron
      • Barcelona, Spain, 8036
        • Hospital Clinic I Provincial
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
  • Ukraine
      • Kharkov, Ukraine, 61070
        • Kharkov Regional Onc Ctr
      • Kherson, Ukraine, 73000
        • Kherson Regional Onc Ctr
      • Odessa, Ukraine, 65055
        • Odessa Regional Onc Ctr
      • Zaporizhia, Ukraine, 69096
        • Zaporizhia Medical Academy of Postgraduate Education
    • UK
      • Dnepropetrovsk, UK, Ukraine, 49102
        • Dnepropetrovsk City Hosp #4
      • Donetsk, UK, Ukraine, 83092
        • Donetsk Regional Antitumor Ctr
      • Kirovohrad, UK, Ukraine, 25031
        • Kirovohrad Regional Oncology Center, Department of Chemotherapy
      • Kyiv, UK, Ukraine, 03022
        • National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum
      • Kyiv, UK, Ukraine, 3039
        • Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery
      • Lutsk, UK, Ukraine, 43018
        • Volyn Regional Oncology Center Department of Oncochemotherapy
      • Lviv, UK, Ukraine, 79031
        • Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr
      • Zhytomyr, UK, Ukraine, 10008
        • O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Comprenhensive Cancer Center at University of Alabama
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute Oncology Specialities, P.C.
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • TGen Clinical Research Services at Scottsdale Healthcare
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic-Scottsdale
      • Sedona, Arizona, United States, 86336
        • Northern Arizona Hematology and Oncology Associates-AOA
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center, University of Arizona
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Cancer Research Foundation
      • Duarte, California, United States, 91010
        • City of Hope
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Los Angeles, California, United States, 90024
        • UCLA
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • University Cancer Institute, LLC
      • Boynton Beach, Florida, United States, 33435
        • Collaborative Research Group
      • Fort Myers, Florida, United States, 33916
        • FL Cancer Specialist
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
      • Ocala, Florida, United States, 34471
        • Ocala Oncology Center
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Tavares, Florida, United States, 32778
        • Lake County Oncology and Hematology
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Putney Cancer Center
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care, LLC
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialists
      • Atlanta, Georgia, United States, 30342
        • Atlanta Cancer Care
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital Research Institute
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Cancer Care & Hemaotology Specialists of Chicagoland
      • Evanston, Illinois, United States, 60021
        • NorthShore University Healthsystem
      • Niles, Illinois, United States, 60714
        • Cancer Care & Hematology Specialists of Chicagoland
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
      • Skokie, Illinois, United States, 60076
        • Orchard Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Simon Cancer Center
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic, Pa
    • Kentucky
      • Louisville, Kentucky, United States, 40245
        • Owsley Brown Frazier Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology Oncology Clinic
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Medical Center
      • Portland, Maine, United States, 04102
        • Mercy Hospital Portland, ME
      • Scarborough, Maine, United States, 04074
        • Maine Center For Cancer Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comphrensive Cancer Center, John Hopkins University
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer & Blood Disorders
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
      • Worcester, Massachusetts, United States, 01655
        • Cancer Center of Excellence/University of MA Medical School
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's/ Duluth Clinic
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota, Masonic Cancer Center
      • Minneapolis, Minnesota, United States, 55408
        • Virginia Piper Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
      • Springfield, Missouri, United States, 65807
        • St. John's Medical Research Institute
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • The Center for Cancer and Hematologic Disease
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Hem Onc Associates-NM
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology PC
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Lake Success, New York, United States, 11042
        • Arena Oncology Associates, PC
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Hematology Oncology
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
      • Columbus, Ohio, United States, 43219
        • Mid Ohio Oncology/Hematology Inc
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical Research Center, LLC
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Cancer Centers of SW OK
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Science Center
      • Oklahoma City, Oklahoma, United States, 73112
        • Mercy Physicians Of Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Cancer Care Associates- Tulsa
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary Medical Center Hem-Onc Group, PC
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburg Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology Hematology Associates
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology
    • Texas
      • Dallas, Texas, United States, 75230-2510
        • Medical City Dallas-US Oncology
      • Dallas, Texas, United States, 75231-4400
        • Texas Oncology, PA
      • Dallas, Texas, United States, 75237
        • Texas Oncology, PA/ Methodist Charlton Cancer Center
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology Laboratories
      • Houston, Texas, United States, 77030
        • The University of Texas Medical School at Houston
      • Plano, Texas, United States, 75075
        • Texas Oncology- Plano East
      • Round Rock, Texas, United States, 76885
        • Texas Oncology, PA
      • Round Rock, Texas, United States, 78681
        • Texas Oncology-Round Rock
      • San Antonio, Texas, United States, 78229
        • South Texas Oncology and Hematology, P.A
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology, PA
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Fairfax-Northern Virginia Hematology-Oncology, P.C.
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialist, PC
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • Richmond, Virginia, United States, 23298-0037
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98104
        • Swedish Health Services
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology & Oncology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

A participant will be eligible for inclusion in this study only if all of the following criteria are met:

  1. Participant has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Participants with islet cell neoplasms are excluded.
  2. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
  3. Patient has one or more metastatic tumors measurable by Computed Tomography (CT) scan or Magnetic resonance imaging (MRI), if patient is allergic to CT contrast media).

  4. Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta-Human Chorionic Gonadotropin (β-hCG) documented 72 hours prior to the first administration of study drug.

    If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual.

  5. Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study.

  6. Patient has adequate biological parameters as demonstrated by the following blood counts at Baseline (obtained ≤14 days prior to randomization):

    Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100,000/mm^3 (100 × 10^9/L); Hemoglobin (Hgb) ≥ 9 g/dL.

  7. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):

    Aspartate Transaminase (AST), Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Transaminase ( ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed Total bilirubin ≤ ULN Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m^2, lean body weight should be used instead.

  8. Patient has acceptable coagulation studies (obtained ≤14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (± 15%).
  9. Patient has no clinically significant abnormalities in urinalysis results (obtained ≤14 days prior to randomization).
  10. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.
  11. Patients should be asymptomatic for jaundice prior to Day 1. Significant or symptomatic amounts of ascites should be drained prior to Day 1. Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1.
  12. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.

Exclusion Criteria

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

  1. Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
  2. Patient has only locally advanced disease.
  3. Patient has experienced a ≥10% decrease in KPS between baseline visit and within 72 hours prior to randomization.
  4. Patient has a ≥20% decrease in serum albumin level between baseline visit and within 72 hours prior to randomization.
  5. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
  6. Patient uses Coumadin.
  7. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  8. Patient has known historical or active infection with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
  9. Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
  10. Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics (SmPC) or Prescribing Information.
  11. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
  12. Patients with a history of interstitial lung disease.
  13. History of chronic leukemias (e.g., chronic lymphocytic leukemia).
  14. Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
  15. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).
  16. Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
  17. Patient is enrolled in any other clinical protocol or investigational trial.
  18. Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Albumin-bound paclitaxel (ABI-007)/Gemcitabine
ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest.
Drug: Albumin-bound paclitaxel (ABI-007)
ABI-007 125 mg/m^2 administered by intravenous infusion
Other Names:
  • Abraxane
Drug: Gemcitabine
Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).
Other Names:
  • Gemzar
Active Comparator: Gemcitabine
Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).
Drug: Gemcitabine
Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) by Independent Radiological Review (IRR)
Time Frame: Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.
Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.
Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.
Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
Time Frame: Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participants With Treatment Emergent Adverse Events (AE)
Time Frame: Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.
Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
Number of Participants With Dose Reductions
Time Frame: Maximum time on treatment was 666 days
The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Maximum time on treatment was 666 days
Number of Participants With Dose Interruptions
Time Frame: Maximum time on treatment was 666 days
The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Maximum time on treatment was 666 days
Number of Participants With Dose Delays/Doses Not Given
Time Frame: Up to 666 days
The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.
Up to 666 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Von Hoff, MD, Scottsdale Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 17, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA046

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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