Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:March 1, 2017
End Date:March 31, 2020
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:Clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Meta Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in
participants with metastatic pancreatic cancer as measured by overall survival.

This is an open-label, multi-center, randomized, Phase 3 study designed to compare the
efficacy and safety of pegilodecakin in combination with FOLFOX versus FOLFOX alone in
participants with metastatic adenocarcinoma of the pancreas who have progressed on one prior
gemcitabine containing regimen.

Inclusion Criteria:

1. The presence of metastatic pancreatic adenocarcinoma

2. Measurable disease per RECIST v.1.1

3. Participant must have documented tumor progression during or following a gemcitabine
containing regimen to treat metastatic disease as established by CT or MRI scan

4. Eastern Cooperative Oncology Group Performance Status of 0 - 1

5. Participant must have completed prior chemotherapy at least 2 weeks (washout period)
prior to randomization and recovered from toxicity to Grade 1 or baseline

6. Participants must not have received previous radiation therapy or investigational
therapy for the treatment of advanced metastatic disease.

7. Participants having received cytotoxic doses of gemcitabine or any other chemotherapy
in the adjuvant setting are not eligible for this study

8. No peripheral neuropathy

9. No known history of dihydropyrimidine dehydrogenase deficiency

Exclusion Criteria:

1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma
(i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or
cystadenocarcinoma

2. Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa
inhibitor with half-life of less than 24 hours.

3. Participant has received prior treatment with pegilodecakin or
fluoropyrimidine/platinum containing regimen

4. Participants who were intolerant of a gemcitabine containing regimen.

5. History of positivity for human immunodeficiency virus

6. Chronic active or active viral hepatitis A, B, or C infection

7. Clinically significant bleeding within two weeks prior to randomization (e.g.,
gastrointestinal (GI) bleeding, intracranial hemorrhage)

8. Pregnant or lactating women

9. Participants with a history of immune-mediated neurological disorders such as multiple
sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders

10. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks

11. Major surgery, defined as any surgical procedure that involves general anesthesia and
a significant incision (i.e., larger than what is required for placement of central
venous access, percutaneous feeding tube, or biopsy),within 28 days prior to
randomization or anticipated surgery during the study period

12. Prior history of receiving immune modulators including, but not limited to,
anti-CTLA4, anti-PD1, anti-PD-L1
We found this trial at
66
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529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
Principal Investigator: Adam A Rojan
Phone: 502-852-2891
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Charles Lopez
Phone: 503-494-3131
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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220 S Palisade Dr # 204
Santa Maria, California 93454
Principal Investigator: Robert Alan Dichmann
Phone: 3602522500
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Arlington Heights, Illinois 60005
Principal Investigator: Richard Siegel
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Athens, Georgia 30607
Principal Investigator: Petros G Nikolinakos
Phone: 513-761-4100
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Austin, Texas 78705
Principal Investigator: Mika Cline-Burkhardt
Phone: 512-421-4100
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Bakersfield, California 93309
Principal Investigator: Shekar Chandra Kota
Phone: 3602522500
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Yousuf A Gaffar
Phone: 206-448-4082
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baton Rouge, Louisiana 70809
Principal Investigator: Gerald Miletello
Phone: 225-767-0822
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Blue Island, Illinois 60406
Principal Investigator: Subramanya Rao
Phone: 708-388-2245
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Boca Raton, Florida 33486
Principal Investigator: Warren S Brenner
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Boston, Massachusetts 02215
Principal Investigator: Andrea Bullock
Phone: 617-632-3029
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Bridgeton, Missouri 63044
Principal Investigator: Juan Daniel Cuevas
Phone: 3142913312
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Caldwell, Idaho 83605
Principal Investigator: Kerry Pulver
Phone: 208-367-7676
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Y Gabrail
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Chattanooga, Tennessee 37401
Principal Investigator: Robert Matthew Graham
Phone: 2064484082
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: Mark Johns
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Dallas, Texas 75246
Principal Investigator: Anish Meerasahib
Phone: 214-820-8799
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: JAMES L. WADE
Phone: 217-876-6639
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Denver, Colorado 80218
Principal Investigator: Sujatha Nallapareddy
Phone: 303-430-2700
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Niharika Mettu
Phone: 919-668-5111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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East Setauket, New York 11733
Principal Investigator: David Chu
Phone: 206-448-4082
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Edgewood, Kentucky 41017
Principal Investigator: Ivan Bedoya-Apraez
Phone: 513-761-4100
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Fort Wayne, Indiana 46815
Principal Investigator: Sunil Babu
Phone: 360-252-2500
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Fullerton, California 92835
Principal Investigator: David J Park
Phone: 321-843-8370
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Gettysburg, Pennsylvania 17325
Principal Investigator: Tina Khair
Phone: 717-334-4033
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Gilbert, Arizona 85234
Principal Investigator: TOMISLAV DRAGOVICH
Phone: 480-256-6444
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Goodyear, Arizona 85338
Principal Investigator: Alan Tan
Phone: 623-207-3000
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Green Bay, Wisconsin 54308
Principal Investigator: Michael Thompson
Phone: 513-761-4100
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Hollywood, Florida 33021
Principal Investigator: Jennifer Zikria
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Jacksonville, Florida
Principal Investigator: Robert Zaiden
Phone: 904-202-7300
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Lakeland, Florida 33805
Principal Investigator: Neeharika Makani
Phone: 863-687-1322
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Longview, Texas 75601
Principal Investigator: Linda S. Couch
Phone: 210-595-5300
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1441 Eastlake Avenue
Los Angeles, California 90033
Principal Investigator: Heinz-Josef Lenz
Phone: 323-409-7148
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Joel Randolph Hecht
Phone: 310-794-1816
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Louisville, Kentucky 40207
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Midland, Texas 79701
Principal Investigator: David L Watkins
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Paul S Ritch
Phone: 414-805-2715
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Alexander Hindenburg
Phone: 516-663-2004
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Minneapolis, Minnesota 55408
Principal Investigator: Tim Larson
Phone: 206-448-4082
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: Johanna Chock Bendell
Sarah Cannon Cancer Center People who live with cancer
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Mark S Womack IV
Phone: 423-698-1844
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Newnan, Georgia 30265
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Hassan Hatoum
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Orlando, Florida 32806
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Orlando, Florida 32804
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Park Ridge, Illinois 60068
Principal Investigator: Edward James
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Philadelphia, Pennsylvania 19124
Principal Investigator: Ankur Parikh
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625 North 6th Street
Phoenix, Arizona 85013
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Plano, Texas 75075
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Redondo Beach, California 90277
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Richmond, Virginia 23235
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San Antonio, Texas 78229
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Scarborough, Maine 04074
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Spokane, Washington 99208
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Summit, New Jersey 07901
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Sydney, New South Wales
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Tacoma, Washington 98002
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Phone: 253-403-7249
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721 Clinic Drive
Tyler, Texas 75701
Principal Investigator: Arielle Lee
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Tyler, Texas 75702
Principal Investigator: Donald A Richards
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Principal Investigator: Michael Jon Pishvaian
Phone: 2026871506
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Wichita Falls, Texas 76310
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Winston-Salem, North Carolina 27103
Principal Investigator: Heather H Shearer
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Worcester, Massachusetts 01655
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