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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00844649
First received: February 13, 2009
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

Phase III Metastatic Pancreatic Cancer


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: Albumin-bound paclitaxel
Drug: Gemcitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Dose Reductions [ Time Frame: Maximum time on treatment was 666 days ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Dose Interruptions [ Time Frame: Maximum time on treatment was 666 days ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Dose Delays/Doses Not Given [ Time Frame: Up to 666 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 861
Study Start Date: May 2009
Study Completion Date: April 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albumin-bound paclitaxel /Gemcitabine
Albumin bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 7 weeks followed by one week of rest in Cycle 1, then weekly administration for 3 weeks, followed by a week of rest in Cycle 2 and onward.
Drug: Albumin-bound paclitaxel
ABI-007 125 mg/m2 administered as an intravenous infusion
Other Name: Abraxane ABI-007
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/m^2 administered by intravenous infusion
Other Name: Gemzar

Detailed Description:

A Phase III, open-label randomized, multicenter trial to compare 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 in participants diagnosed with metastatic adenocarcinoma of the pancreas.

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

  1. Patient 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. Patients 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 scan (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 aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (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 Cockcroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m2, 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844649

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

No publications provided by Celgene Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00844649     History of Changes
Other Study ID Numbers: CA046
Study First Received: February 13, 2009
Results First Received: October 21, 2013
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Italy: The Italian Medicines Agency
Canada: Health Canada
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014