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



Status:Completed
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:8/10/2018
Start Date:April 20, 2015
End Date:September 2017

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A 3-Arm Phase 2 Double-Blind Randomized 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

This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic
pancreatic ductal adenocarcinoma.

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.


Inclusion Criteria:

1. Subjects must have histologically confirmed metastatic pancreatic ductal
adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or
neoadjuvant setting or for metastatic disease is not allowed.

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:

1. Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas
or a pancreatic tumor with mixed histologies.

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
We found this trial at
23
sites
Randwick, New South Wales 2031
Principal Investigator: David Goldstein, MD
Phone: (02) 9382 2581
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Davendra Sohal, MD
Phone: 216-636-5128
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Benjamin Musher, MD
Phone: 713-798-8810
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Marcus Noel, MD
Phone: 585-275-8213
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Vallejo, California 94589
Principal Investigator: TATJANA KOLEVSKA, MD
Phone: 707-651-2797
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Vallejo, CA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Mark Zalupski, MD
Phone: 734-936-9238
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Boca Raton, Florida 33486
Principal Investigator: Warren Brenner, MD
Phone: 561-955-4800
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501 S Buena Vista St
Burbank, California 91505
(818) 843-5111
Principal Investigator: Raul Mena, MD
Phone: 818-748-4778
Providence Saint-Joseph Medical Center Located just north of Los Angeles, Providence Saint Joseph Medical Center...
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Denver, Colorado 80218
Principal Investigator: Allen Cohn, MD
Phone: 303-285-5004
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Duarte, California 91010
Principal Investigator: Vincent Chung, MD
Phone: 626-256-4673
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Gilbert, Arizona 85234
Principal Investigator: Madappa Kundranda, MD
Phone: 480-256-6444
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Laith Ismail Mahmoud Abushahin, MD
Phone: 319-353-8914
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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La Jolla, California 92037
Principal Investigator: Darren Sigal, MD
Phone: 858-554-9379
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Lebanon, New Hampshire 03756
Principal Investigator: J. Marc Pipas, MD
Phone: 603-650-6380
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Lubbock, Texas 79410
Principal Investigator: Ibrahim A. Shalaby, MD
Phone: 806-725-7993
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New Orleans, Louisiana 70121
Principal Investigator: Jyotsna Fuloria, MD
Phone: 504-842-4498
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Philadelphia, Pennsylvania 19107
Principal Investigator: Ashwin Sarna, MD
Phone: 215-955-3773
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Portland, Oregon 97227
Phone: 503-249-3506
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Sacramento, California 95817
Principal Investigator: Edward J Kim, MD, PhD
Phone: 916-734-1455
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Ignacio Garrido-Laguna, MD
Phone: 801-585-0115
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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San Marcos, California 92078
Principal Investigator: Jonathan Polikoff, MD
Phone: 909-427-7103
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750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Rahul Seth, MD
Phone: 315-464-8240
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Westwood, Kansas 66205
Principal Investigator: Joaquina Baranda, MD
Phone: 913-945-6594
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