Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
NCT ID: NCT02289898
Last Updated: 2020-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
207 participants
INTERVENTIONAL
2015-04-20
2017-09-30
Brief Summary
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The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Abraxane® and gemcitabine plus placebo
Abraxane® and gemcitabine plus placebo (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
Demcizumab
administered intravenously
Abraxane®
administered intravenously
gemcitabine
administered intravenously
Placebo
Abraxane® and gemcitabine plus demcizumab plus placebo
Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
Demcizumab
administered intravenously
Abraxane®
administered intravenously
gemcitabine
administered intravenously
Abraxane® and gemcitabine plus demcizumab
Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus demcizumab (3 cycles) and then Abraxane® and gemcitabine until disease progression
Demcizumab
administered intravenously
Abraxane®
administered intravenously
gemcitabine
administered intravenously
Interventions
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Demcizumab
administered intravenously
Abraxane®
administered intravenously
gemcitabine
administered intravenously
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization.
3. Age ≥21 years
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Measurable disease per RECIST v1.1
5. Adequate organ and marrow function
6. Signed Informed Consent Form
7. For women of childbearing potential, agreement to use two effective forms of contraception
Exclusion Criteria
2. Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
3. Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
4. Subjects with Grade \>2 peripheral neuropathy
5. Subjects with clinically significant ascites
6. Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
7. Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
8. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
9. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
10. Pregnant women or nursing women
11. Subjects with known HIV infection
12. Known bleeding disorder or coagulopathy
21 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
OncoMed Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Providence Saint Joseph Medical Center
Burbank, California, United States
City of Hope
Duarte, California, United States
Scripps Cancer Center
La Jolla, California, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
Soulhern California Permanente Medical Group
San Marcos, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Lynn Cancer Institute
Boca Raton, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
University of Rochester
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Kaiser Permanente NW Oncology Research
Portland, Oregon, United States
Thomas Jefferson University, Sydney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Joe Arrington Cancer Research Treatment Center
Lubbock, Texas, United States
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Monash Medical Centre, Moorabbin
Bentleigh East, Victoria, Australia
Western Health (Sunshine Hospitals)
St Albans, Victoria, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia
St. John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Hopital Erasme
Brussels, Brussels Capital, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
London Regional Cancer Program
London, Ontario, Canada
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
St Josephs Health Centre
Toronto, Ontario, Canada
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO)
Barcelona, , Spain
Hospital General Universitario Gregorio Marafi6n
Madrid, , Spain
Hospital Universitario de Fuenlabrada
Madrid, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Bristol Haematology & Oncology Centre
Bristol, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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M18-006
Identifier Type: -
Identifier Source: org_study_id
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